Category Archives: Insights

Clinical trials in Australia: where sponsor teams need support most

Australia continues to attract attention as a destination for early-phase and sponsor-led studies.

The reasons are well understood. Faster start-up, a strong clinical research environment and a more efficient pathway into early development all make Australia commercially and operationally attractive.

But choosing Australia is not the same as being ready to run well in Australia.

For many lean sponsor teams, the real challenge starts once a study moves from planning into delivery. That is the point where local oversight, safety governance, medical decision-making and operational responsiveness begin to matter in a much more practical way.

Why Australia remains attractive for sponsors

Australia remains attractive for a number of practical reasons.

For early-phase and exploratory studies, it offers a combination of speed, regulatory clarity and high-quality research infrastructure that is hard to ignore. For biotech teams working with limited internal resource, it can provide a more efficient route into clinical development than many other markets.

That is why Australia is often seen as a smart strategic choice, particularly for sponsors looking to move quickly without compromising study quality.

But the sponsors that tend to do this well are usually the ones that recognise local execution still depends on the right medical and operational support being in place from the outset.

In practice, three factors continue to make Australia especially attractive:

faster study start-up timelines
a clear and efficient early-phase pathway
strong research capability and high-quality sites

What lean sponsor teams tend to underestimate

In early planning, a study can look relatively manageable on paper.

In practice, once recruitment starts, safety data begins to accumulate and protocol decisions need to be made in real time, the pressure on a lean sponsor structure increases quickly.

For many teams, the challenge is not scientific capability. It is access to experienced medical support at the point where decisions need to be made quickly and confidently.

That usually shows up in familiar areas:

medical monitoring and safety review
protocol deviation and eligibility assessment
investigator support
dose escalation and safety governance
continuity across local and global teams

This is often the point where a study starts to feel more operationally demanding than expected.

Where sponsor teams usually need support first

Medical monitoring and safety oversight

Once a study is live, timely physician-led review becomes essential. Safety signals, adverse events, eligibility questions and protocol issues all need prompt assessment, particularly in early-phase settings where decision-making can directly affect study progression.

Dose escalation and governance

In first-in-human and dose-escalation studies, the quality of safety review and committee preparation can materially affect both confidence and pace. This is one of the areas where experienced external medical support can add immediate value.

Sponsor-side medical leadership

Lean biotech teams often do not need to build a large permanent structure. What they do need is senior medical input that can act as an extension of the sponsor team, support the CRO and provide oversight as complexity increases.

Regional coordination

Even where Australia is the initial market, studies rarely stay operationally simple for long. As programmes evolve, sponsors often need local and regional medical input that can support continuity without slowing the model down.

What this looks like in practice

We have supported sponsor teams across early-phase and global studies where medical oversight needed to be strengthened without building a large internal infrastructure.

That has included physician-led support through dose escalation and safety governance in first-in-human oncology, sponsor-side medical leadership for lean clinical-stage biotech teams and high-volume medical monitoring across complex multi-country programmes.

For sponsors considering Australia, the requirement is often similar: experienced medical support that can integrate quickly, support decision-making and maintain continuity as programme complexity increases.

“One of the best SRC meetings I have experienced in terms of preparation and execution.” Chief Medical Officer, oncology biotech sponsor

How MMD supports sponsor teams

My Medical Department supports clinical development with physician-led medical expertise across early and late-phase studies.

That includes:

medical monitoring
safety governance
dose escalation support
protocol and eligibility review
investigator support
sponsor-side medical leadership
medical writing and study documentation
continuity across global and regional delivery

For lean biotech and sponsor teams, that means access to experienced medical support without needing to build permanent infrastructure before it is truly needed.

Where to find us in June

MMD will be at ARCS Australia 2026 from 10–12 June at ICC Sydney, where we will be at Booth 55 and are proud to be sponsoring the conference photo wall.

If you are attending and would like to compare notes on Australian clinical trials, medical monitoring or sponsor-side medical support, please reach out to our team in advance at enquiries@mymedicaldepartment.com to arrange a meeting.

A final thought

Australia may offer an attractive route into early clinical development, but successful delivery still depends on how well the study is supported once it starts moving.

The sponsors that navigate this best are not always the ones with the biggest internal teams.

They are usually the ones that recognise early where experienced medical oversight will make the greatest difference and build that support in before timelines become fragile.

If you are planning or running a study in Australia and would like to sense-check where support is likely to matter most, please contact us at enquiries@mymedicaldepartment.com.

How pharma teams are adding senior medical cover without adding headcount

Across pharma and biotech teams, the conversation is shifting.

The challenge is no longer only how to respond once pressure becomes visible. It is how to build enough senior medical capacity into the model before review timelines start to slip, signatory responsibility becomes too concentrated or regional coverage becomes harder to sustain.

In many teams, the issue is not a lack of expertise. It is that the expertise exists in too narrow a bandwidth.

That is where delivery starts to feel fragile.

What is changing

Over recent months, we have seen a clearer pattern emerge across client conversations and active engagements.

Teams are becoming more deliberate about how they access senior medical expertise. Not only through permanent hires, but through interim, fractional and specialist support that can be introduced at the point where continuity matters most.

That shift is showing up in three places in particular.

1. Interim medical cover is becoming more strategic

Interim support used to be viewed mainly as a short-term solution.

Increasingly, it is being used more deliberately.

For many organisations, permanent headcount cannot move quickly enough to absorb sudden peaks in review demand, launch activity, congress preparation or programme expansion. Waiting until the pressure becomes obvious often means the delay is already under way.

The teams managing this well are using flexible senior medical support earlier, as a way to protect continuity rather than recover it.

2. Signatory pressure is harder to absorb

One of the clearest pressure points remains signatory and senior review capacity.

In theory, workflow may look manageable. In practice, the strain often sits with a very small number of people carrying responsibility for final medical judgement, approval and escalation.

That concentration creates risk quickly.

Review timelines become less predictable. Decisions take longer to land. Work begins queueing behind a handful of senior individuals whose capacity is already stretched.

In our experience, this is one of the areas where fractional or interim support can make the most immediate difference, particularly when demand rises faster than internal structures were built to handle.

3. Regional expertise is being added more flexibly

As programmes expand across Europe, APAC and beyond, medical delivery becomes more complex.

What looks manageable from a global planning perspective can become much harder to sustain at regional level when medical affairs, regulatory interpretation and local execution all need timely senior input.

We are seeing more teams look for flexible regional support rather than waiting for permanent structures to catch up.

That is especially true where timelines are moving quickly, local nuance matters and there is limited tolerance for delay.

Where we are seeing demand for senior medical cover most often

The practical need is usually showing up in familiar areas:

Peak MLR review demand and final signatory cover
Interim and fractional Medical Affairs support
Medical monitoring reinforcement during active programme phases
Regional medical input across Europe and APAC
Flexible senior input around launch, submission and milestone pressure

These are not isolated issues. They are often connected.

When one part of the model becomes too dependent on a small number of senior people, the knock-on effect is felt across the wider programme.

What usually prompts teams to act

By the time support is being actively explored, the early signs are often already visible:

Review timelines becoming less predictable
Signatory work concentrating in too few people
Regional medical input becoming harder to maintain
Milestones putting visible strain on existing medical resource
Teams becoming increasingly dependent on one or two senior decision-makers

Usually, none of these issues looks dramatic in isolation.

Together, they are a strong signal that continuity needs strengthening.

How MMD is responding

This April, My Medical Department marked 12 years of supporting pharmaceutical, biotech and life sciences teams with physician-led medical expertise.

Over that time, our role has remained consistent. We help clients access senior medical support when quality, continuity and timely decision-making matter most.

We have also recently strengthened our UK Medical Affairs capability with the appointment of Linnea Lindqvist-Brown, whose background includes AstraZeneca, Eisai, Roche and Pfizer, alongside ABPI Final Signatory experience.

That addition reflects something we are seeing clearly in the market. Clients increasingly need experienced support that can be deployed quickly, credibly and in a way that fits the realities of modern medical delivery.

A final thought

The most resilient teams are not always the ones with the largest structures.

They are often the ones that think earlier about continuity, senior decision-making capacity and how specialist expertise can be added without slowing everything else down.

That is where interim and fractional medical support is becoming more strategic.

And it is why more organisations are treating flexible senior medical cover not as a backup plan, but as part of how delivery is protected in the first place.

If your team is reviewing how to strengthen medical capacity without adding permanent headcount too quickly, we would be very happy to compare notes. Contact us at enquiries@mymedicaldepartment.com or visit www.mymedicaldepartment.com.

Where Pharmaceutical Programmes Start to Slow Down

Executive Briefing · March 2026

Where Pharmaceutical Programmes Start to Slow Down

Across clinical development, medical affairs and global programme delivery, one issue is showing up more consistently right now. It is rarely a lack of expertise. More often, it is a lack of alignment — and by the time it becomes visible, it is usually already affecting timelines.

Kwesi Ackah Global Director of Strategic Development · My Medical Department

Clinical, medical, regulatory and commercial teams can all be doing strong work individually and still create delay collectively. Not because people are underperforming, but because they are moving at different speeds, under different pressures and without enough structural overlap to catch the gaps before they become bottlenecks.

“The bottleneck is not capability. It is the moment when throughput increases but capacity does not adjust in the same way.”

That usually becomes visible at predictable pressure points — conference periods, team transitions, key milestones, holiday cover and launch preparation. By the time the problem is obvious, it is often already affecting timelines.

Why Australia Is Becoming a Stronger Option for Early-Phase Trials

One of the clearest shifts we are seeing is the continued growth of early-phase and exploratory trial activity in Australia. The reasons are practical.

Speed

Study start-up can be faster than in the US and much of Europe

Regulatory clarity

The regulatory pathway is well understood, particularly for Phase I and II

Cost efficiency

The cost profile can be attractive, particularly in earlier development phases

Site quality

Strong site and investigator capability across the country

From a development strategy perspective, the case is clear. The part that is easier to underestimate is the operating model around it.

Once programmes are spread across regions, time zones and governance frameworks, execution becomes more demanding. The strategic decision may be sound, but the supporting structure does not always evolve at the same pace. That is often where delay begins.

Considering Australia for your next early-phase programme? We work with sponsors navigating this exact challenge across clinical development and regulatory strategy.

Talk to our team about your programme →

Where Bottlenecks Usually Appear in Clinical and Medical Affairs Teams

There are three places where we see this most consistently.

1. Medical Affairs and MLR Review

During high-volume periods, review processes come under pressure quickly. Materials arrive not fully ready. Signatory responsibility is concentrated in too few people. Workflows begin to fragment.

The result is predictable — delays increase, timelines become less reliable and pressure builds between teams at exactly the point when speed matters most.

2. Clinical Development and Medical Monitoring

As programmes scale, safety data is generated continuously. Oversight structures do not always scale with it. Signal interpretation slows. Escalation pathways become less clear across regions. Decision-making latency starts to creep in.

This is rarely dramatic at first. It is usually gradual — but it becomes very obvious once the programme is under pressure.

3. Global and Local Execution

As soon as work needs to move across markets, global strategy has to stay aligned with local requirements, local codes and local expectations. If that alignment is weak, teams end up dealing with inconsistent interpretation, slower approvals and avoidable compliance risk.

Zero

substantiated code complaints relating to MMD-approved materials in over 12 years. Compliance is not a constraint on speed — it is a condition for it.

What High-Performing Pharmaceutical Teams Do Differently

The strongest teams do not simply add more people when pressure appears. They make structural adjustments earlier.

Scaling review and signatory capacity before peak periods rather than during them
Embedding medical input earlier so materials arrive for review genuinely ready
Ensuring medical monitoring models keep pace with data flow rather than lagging behind it
Aligning global and local regulatory thinking before regional differences become execution blockers

In other words, they do not wait for friction to become visible before addressing it.

Early Warning Signs of a Misaligned Programme

A Quick Check

If any of these sound familiar, it is usually a sign that alignment is starting to break down — and worth addressing before timelines tighten further:

Review timelines are becoming less predictable
Increasing back-and-forth between medical and marketing teams
Materials requiring multiple review cycles before reaching approval
Delays linked to limited signatory or senior medical capacity
Bottlenecks appearing during periods that should have been manageable

These issues rarely resolve themselves. They tend to compound as timelines tighten.

“Since partnering with MMD we have found that our materials no longer reach a bottleneck in the copy process. I would recommend them as an agency for companies looking for effective and proactive solution providers.”

Dr Tim Patel

Medical Director UK, Astellas

How My Medical Department Supports Global Programmes

My Medical Department is a physician-led global medical consultancy supporting pharmaceutical and biotech organisations across clinical development, medical affairs and regulatory strategy. Our teams are based in Australia, the UK and Latin America, with project support delivered globally.

We are currently supporting organisations with:

Managing peak MLR review demand and signatory capacity
Implementing continuous medical monitoring in clinical programmes
Strengthening global-to-local regulatory alignment across regions
Strategic consultancy across clinical development, medical affairs and market access

Australia United Kingdom Latin America

Where timelines are already under pressure, small structural changes can make a material difference to delivery. If these are challenges your team is currently facing, get in touch to discuss how others are approaching them in practice.

Let us talk about what you are seeing

We support global programmes with teams in Australia, the UK and Latin America. If timelines are already under pressure, the right time to address it is now.

Talk it through with our team →

No commitment. Just a conversation.

Reflections on My First AusBiotech Conference.

By Dr Manuel Salgado, Medical Director

Attending AusBiotech 2025 in Melbourne was an outstanding experience and a privilege for our team at My Medical Department. As my first time participating in this event, I was truly impressed by the scale of innovation, collaboration and passion driving Australia’s life sciences community.

The conference brought together thought leaders, researchers, clinicians and industry professionals from across biotechnology, pharmaceuticals and medtech. It was a dynamic platform for meaningful conversations about the challenges and opportunities shaping the future of healthcare from early-stage research to commercialisation and patient impact.

Emerging Trends Shaping the Future

Several sessions stood out for their depth and forward-thinking perspectives. The discussions on the integration of artificial intelligence (AI) in drug discovery and development highlighted how automation and data-driven insights are transforming research timelines and improving the precision of decision-making.

Equally inspiring were sessions exploring the emerging field of radiopharmaceuticals, a rapidly growing area where Australia is building strong capability and global recognition. These innovations, combined with our nation’s reputation as a world-class environment for early-phase and Phase I clinical research, reinforce Australia’s position as a preferred destination for high-quality, efficient and ethically robust trials.

My Medical Department’s Role in a Thriving Ecosystem

At My Medical Department, we see enormous potential to contribute to this vibrant ecosystem. As a physician-led global medical consultancy with teams based in Australia, the United Kingdom and Latin America, we deliver 24/7 medical expertise through a multidisciplinary team of Physicians, Pharmacists and Scientists.

Our services span the full spectrum of clinical and medical functions, including:

Medical Monitoring and Safety Oversight
Participation in Safety Review Committees and Data Safety Monitoring Boards (DSMBs)
Regulatory Affairs and Pharmacovigilance
Clinical Development Strategy and Operations
Medical Affairs and Medical Information
Quality Management and Compliance
Local Representation for International Sponsors

Through these capabilities, we support our clients in bringing safe, effective and compliant therapies to patients wherever they are in the product lifecycle.

Looking Ahead

What stood out most to me at AusBiotech 2025 was the spirit of collaboration and innovation. It was energising to see how companies, regulators and researchers are collectively working to build a stronger, more connected life sciences ecosystem. One that prioritises patient safety, scientific integrity and the acceleration of global innovation.

For us at My Medical Department, events like AusBiotech reaffirm our commitment to partnering with forward-thinking organisations to deliver safe, efficient and high-quality clinical development programs. We look forward to deepening the connections made during the conference and contributing to future collaborations that advance healthcare for patients worldwide.

Pharmaceutical Medical Expertise. Anytime. Anywhere.

If we didn’t get the chance to meet during AusBiotech 2025, we’d love to connect.
👉 Reach out via www.mymedicaldepartment.com or contact our team to explore how we can support your next clinical or medical project.

📩 Email us at enquiries@mymedicaldepartment.com
🌐 Visit www.mymedicaldepartment.com

Reflections from MAPS-MAPA Australia: People, Partnerships and the Future of Medical Affairs

The MAPS-MAPA Australia meeting is always a highlight on the calendar, a chance to connect with peers, share ideas and explore how our field continues to evolve. This year was no different. Over the course of the event, our team at My Medical Department (MMD) had the privilege of engaging in some fantastic conversations about the role of innovation, collaboration and technology in shaping the future of medical affairs.

Who We Are and Why We’re Here

As a physician-led, global medical consultancy, My Medical Department (MMD) brings together doctors, pharmacists and scientists across Australia, the UK and Latin America. We provide on-demand medical department functions tailored to organisations of all sizes. Whether it’s medical affairs, regulatory support, pharmacovigilance or medical writing. Our focus is always the same: keeping patients at the centre and delivering safe, scientifically robust solutions.

Being at MAPS-MAPA gave us the opportunity not only to share what we do, but also to listen and learn from others in the community. That exchange of perspectives from colleagues, partners and industry leaders is what makes these events so valuable

Talking AI: Excitement and Responsibility

One of the big topics this year was, unsurprisingly, artificial intelligence. Across the sessions and in countless hallway conversations, people were asking: How do we use AI to make our work better, without losing the human touch?

We’ve seen first-hand how tools like large language models can help with everything from summarising medical calls to creating patient-friendly content. They free up time and headspace so experts can focus on higher-value work. But with that opportunity comes responsibility. Bias, governance and the need for humans to remain firmly “in the loop” were recurring themes and ones we strongly believe in.

Partnering to Shape the Future of AI in Medical Affairs

At MMD, we’re committed to exploring AI responsibly and practically. That means not just adopting tools, but actively partnering with AI providers to test, refine, and validate their solutions in real-world medical affairs contexts.

By working alongside innovators, we help ensure these technologies are safe, compliant, and genuinely useful for the professionals who will rely on them. It’s about blending our physician-led expertise with emerging AI capabilities — ensuring that progress in this space is both exciting and responsible.

At MAPS-MAPA, the conversations we had reinforced just how important this role is. There’s a real appetite across the industry to harness AI, but also a recognition that it must be done with care. Being part of that journey, alongside trusted partners, is something we’re incredibly proud of.

Looking Ahead

As we reflect on MAPS-MAPA Australia, what stands out most are the people: the colleagues we reconnected with, the new relationships we formed and the energy in the room when passionate professionals come together to talk about the future.

AI will undoubtedly become a standard part of how medical affairs teams work. But the real differentiator will be how we as people adopt it, shape it and use it to better serve patients. That’s the future we want to help build at My Medical Department: combining our global expertise, innovative partnerships and patient-first values to support organisations every step of the way.

To everyone who stopped by to talk with us at MAPS-MAPA and enjoyed our cupcakes: thank you. We left inspired, motivated and more convinced than ever that together, we’re shaping a better future for medical affairs.

👉 If you’d like to explore how we can support your organisation, whether through medical affairs expertise, regulatory guidance or responsible adoption of AI. We’d love to start a conversation. Get in touch with us here.

📩 Email us at enquiries@mymedicaldepartment.com
🌐 Visit www.mymedicaldepartment.com

Pharmaceutical Medical Expertise. Anytime. Anywhere.

Tackling Peak Conference Demands in Pharma: How MMD Can Support

Every year, major UK and European medical conferences such as ESMO, EURETINA, ERS and BSH bring an incredible opportunity for pharmaceutical companies to engage with HCPs and showcase their latest scientific data.

But with these opportunities come challenges for medical and marketing teams:

Workload spikes as symposia, booth activities and HCP engagements occur simultaneously within a short period
International colleagues often play a key role in event delivery but may require dedicated support to navigate ABPI Code requirements
Compressed timelines for the review and approval of congress materials
Overlapping leave and escalating demands can place considerable strain on internal medical resources

Why Conference Season Creates Bottlenecks

When conference season hits, internal medical teams are expected to:

Review and approve various materials, including slides, posters and booth content
Respond to real-time medical enquiries and healthcare stakeholder engagements
Maintain compliance oversight, ensuring all activities meet ABPI standards

These demands can quickly outpace available internal resources. Without additional support, the combination of time pressure and increasing workload often leads to bottlenecks, delayed approvals and increased compliance risk.

How My Medical Department Provides Overflow Support

At MMD, we act as an extension of your medical affairs team during peak periods, helping you stay compliant and efficient, while easing the workload.

Among the services we offer:

ABPI-compliant medical review and approval of all congress materials
Overflow and leave cover, so work continues seamlessly
Rapid turnaround, even during busy conference seasons
Guidance for international teams, ensuring local compliance for UK and EU activities

By stepping in as flexible medical support, MMD allows your core team to focus on high-value HCP engagement, knowing that all materials are handled accurately and on time.

Ready for a Smoother Conference Season?

When internal teams are stretched, MMD steps in with specialist support that’s fast, flexible and fully ABPI-compliant. Whether it’s last-minute content reviews or strategic overflow coverage, we help you stay ahead—so your team can focus on delivering scientific excellence where it matters most.

Let’s talk about how we can support your next conference season.

📩 Email us at enquiries@mymedicaldepartment.com
🌐 Visit www.mymedicaldepartment.com

Pharmaceutical Medical Expertise. Anytime. Anywhere.

Why Round-the-Clock Medical Monitoring Is Reshaping Clinical Trial Success

24/7 Medical Monitoring

In today’s clinical research environment, speed and safety are non-negotiable. Whether it’s a Phase I oncology trial or a large-scale global program, the ability to detect risks early, respond to medical queries in real-time and ensure participant safety is essential to a trial’s success.

At My Medical Department, we understand that clinical trials don’t sleep and neither should your medical oversight.

What Is Medical Monitoring?

Medical Monitoring is more than just data review. It’s about active, ongoing medical oversight that ensures patient safety, scientific integrity and protocol compliance across every stage of a clinical trial.

Our services include:

In-depth analysis and interpretation of clinical data
Participation in Safety Review Committees (SRCs) and Data Safety Monitoring Boards (DSMBs)
24/7 availability to address investigator queries and emerging safety signals
Proactive implementation of risk mitigation strategies that safeguard trial integrity

Why 24/7 Matters

Delays in responding to safety concerns can jeopardise more than your timelines. They can compromise patient well-being.

MMD’s trans-global medical monitoring team spanning the UK, Australia and Latin America, enables seamless round-the-clock coverage. Our physicians are available whenever and wherever they’re needed, ensuring no critical signal is missed due to time zone limitations.

This global setup allows us to offer a truly follow-the-sun model, providing continuous oversight without delay.

Built for Risk Mitigation

Every trial carries risk. Our job is to manage it, decisively and expertly.

By identifying potential safety issues early and working closely with investigators, we help our clients prevent protocol deviations, improve data quality and make informed go/no-go decisions faster.

Our experienced physicians don’t just observe, they collaborate, advise and act.

Real Clients, Real Impact

“The MMD team have been a total pleasure to work with during a large, global fast paced trial that requires plenty of medical input for sites and our CRO team across Australia, New Zealand, and the United States.

MMD have always been very prompt to address any questions from sites and kept our CRO teams proactively informed with all the site activities associated to patient safety, eligibility etc.”

Director of Project Management –
Harvest Integrated Research Organization (HiRO)

We’re proud to support companies of all sizes. From emerging biotechs to multinational pharmaceutical leaders and CROS.

Why Choose MMD?

✅ Experienced physicians and scientists
✅ Experience across therapy areas and study phases
✅ 24/7 global availability
✅ Cost-effective, on-demand engagement
✅ Proven track record with global pharma partners

We’re not just a vendor. We are your strategic medical partner, dedicated to keeping your trial on track and your patients safe.

Ready to Enhance Your Trial’s Oversight?

Let’s talk about how our Medical Monitoring service can support your next clinical program.

📩 Email us at enquiries@mymedicaldepartment.com
🌐 Visit www.mymedicaldepartment.com

Pharmaceutical Medical Expertise. Anytime. Anywhere.

Expert Insight: Why a Medical Consultancy Is Better Than a Contractor

Flexible, compliant and built for scale

When timelines are tight, workloads peak or team members head out on leave, the common instinct is to bring in a contractor. It seems quick, straightforward and effective. One person to fill one gap.

But what if your project needs more than just an extra pair of hands?

At My Medical Department, we’re seeing more pharmaceutical, biotech and CRO teams shift away from hiring single interim roles and toward partnering with full-service medical consultancies.

Here’s why that shift makes strategic sense and why it’s paying off in quality, compliance and cost-efficiency.

1. Scalability: A Whole Team, Not Just One Person

Contractors bring value, but they also bring limits. When you hire a contractor, you’re hiring one CV. When you partner with a consultancy, you gain access to a network of professionals across specialties: medical advisors, PV scientists, medical writers, regulatory experts and more.

Need support across multiple functions at once? We scale instantly, no recruitment cycle required.

2. Speed: Plug-and-Play, No Onboarding Delay

Consultancies like MMD are built for rapid deployment. Our systems, processes and quality standards are already in place and our team is trained and aligned.

There’s no lengthy onboarding, IT setup or compliance delays. Just a tailored kickoff and immediate delivery.

3. Continuity: No Holiday Gaps, No Drop-Offs

Contractors get sick. They go on leave. And when they leave a project, the handover risk is high.

Our consultancy model provides global 24/7 coverage, with cross-trained teams in the UK, Australia and LATAM. That means no service gaps even during the summer or end-of-year slowdowns.

“Out of office” doesn’t mean out of action.

4. Breadth of Expertise: Integrated Functions, One Partner

Today’s medical and regulatory functions don’t exist in silos. Yet when companies hire multiple contractors across PV, Medical Affairs and Regulatory alignment suffers.

We provide cross-functional support that is coordinated, compliant and collaborative. Reducing internal friction and improving output quality.

5. Cost Efficiency: Pay for What You Use

Contractors often come with agency fees, fixed-term contracts and overhead costs that can add up fast. Especially when projects evolve.

With MMD, you only pay for what you need, when you need it. We offer both retainer and project-based options, giving you maximum flexibility without compromising delivery.

Why MMD?

We’re more than a stopgap. We’re a strategic extension of your medical team.

✔️ Physician-led
✔️ Globally available
✔️ Inspection-ready
✔️ Fully integrated with your internal systems

Whether you need a full department or a single function, we help you move faster, stay compliant and reduce internal strain.

Explore our website here to learn more about My Medical Department and how we can support your organisation.

Regulatory Roundup – May 2025

Welcome to the May 2025 edition of our Regulatory Roundup! This month, we bring you the latest updates from key regulatory bodies worldwide, including the Therapeutic Goods Administration (TGA) in Australia, the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA).

These updates highlight significant strides in medical regulation, from consultations on in vitro diagnostic (IVD) medical device classifications to advancements in artificial intelligence integration within regulatory processes. Additionally, we provide expert tips to streamline your copy approval processes, ensuring efficiency and compliance.

Stay informed about the latest regulatory changes and how they might impact your work and industry.

🇦🇺 Therapeutic Goods Administration (TGA)

IVD Classification Consultation: The TGA actively seeks stakeholder feedback on proposed changes to in vitro diagnostic (IVD) medical device classifications and definitions. This initiative aims to align Australia’s regulations with the European Regulation 2017/746. Stakeholders have until 23 May 2025 to submit their feedback.

Nitrosamine Impurities Update: On 30 April 2025, the TGA updated its guidelines regarding acceptable intake levels for nitrosamine impurities in medicines. This update aligns with recent changes made by the European Medicines Agency (EMA), ensuring consistency in safety standards.

Learn More

🇺🇸 U.S. Food and Drug Administration (FDA)

AI Integration in Reviews: The FDA has announced a significant step forward in its regulatory processes by integrating artificial intelligence tools across all its centres. Full integration is expected by 30 June 2025, following a successful generative AI pilot to streamline the drug approval process.

COVID-19 Vaccine Advisory Meeting: An advisory committee meeting is scheduled for 22 May 2025 to discuss and make recommendations on selecting the 2025–2026 formula for COVID-19 vaccines in the U.S. This meeting will play a crucial role in shaping the upcoming vaccination strategy.

Learn More

🇪🇺 European Medicines Agency (EMA)

Advanced Therapies GMP Revision: On 8 May 2025, the EMA published a concept paper proposing revisions to Part IV guidelines on good manufacturing practice (GMP) specific to advanced therapy medicinal products. This revision aims to enhance the regulatory framework for these innovative therapies.

Data and AI Workplan: In collaboration with the Heads of Medicine Agencies, the EMA has released a joint work plan titled “Data and AI in medicines regulation to 2028.” This strategic document outlines plans to leverage data and artificial intelligence to improve regulatory processes and outcomes.

Learn More

As we navigate the evolving landscape of medical regulation, it is crucial to stay informed about the latest updates from key regulatory bodies. The May 2025 Regulatory Roundup has highlighted significant TGA, FDA, and EMA developments, showcasing efforts to enhance regulatory frameworks and integrate advanced technologies.

We hope this roundup provides valuable insights and helps you stay ahead in your field. Look for future updates, and don’t hesitate to share your thoughts or questions. Together, we can continue to drive progress and innovation in medical regulation.

Thank you for reading, and stay tuned for next month’s roundup!

Navigating the Complexities of Copy Approval in the Pharma Industry.

Introducing Pharmaceutical copy approval.

The pharmaceutical industry, which is known for its stringent regulations and meticulous attention to detail, particularly in the approval of promotional and non-promotional materials, places significant emphasis on the copy approval process. This process, a pivotal component of pharmaceutical operations, is designed to ensure compliance with regulatory standards, maintain the integrity of information, and uphold the industry’s reputation. Therefore, pharmaceutical companies cannot overstate its importance, as it is a key factor in bringing products to market efficiently and ethically.

Adherence to guidelines.

At the heart of the copy approval process is the need to adhere to the guidelines set forth by regulatory bodies such as the Prescription Medicines Code of Practice Authority (PMCPA) and the Medicines and Healthcare Products Regulatory Agency (MHRA). These organisations mandate that all promotional materials undergo rigorous review and certification to ensure they meet the highest standards of accuracy and compliance. The PMCPA’s Guidance on Certification emphasises that certification is typically the final step involving multiple reviews by various staff members before final approval. This multi-layered approach can catch errors or inconsistencies that could lead to code breaches and subsequent sanctions.

Primary challenges in copy approval.

One of the primary challenges in the copy approval process is the sheer volume of materials that need reviewing. From origination to uploading, review, certification, and archiving, each step requires meticulous attention to detail and a thorough understanding of regulatory requirements. Fundamental errors in this process can have serious consequences, as evidenced by past cases where companies faced sanctions due to flaws in their copy approval systems. To mitigate these challenges, the industry has seen the introduction of Appropriately Qualified Persons (AQPs) under the new ABPI Code of Practice. This pragmatic move aims to reduce the approval burden on signatories and streamline the process. For example, AQPs can now check printed materials against the final certified electronic version. Whilst, the previous argument was that this talk is more of an identity check than a compliance one. Additionally, AQPs can certify meeting arrangements for UK health professionals travelling to overseas meetings, further alleviating the workload of medical signatories.

Digital tools for copy approval.

Despite these advancements, the copy approval process remains complex and often lengthy. The introduction of digital tools and paperless validation systems has brought about significant changes, offering new ways to handle verification and validation while maintaining compliance with current regulations. Authentic Copy Verification practices, for instance, ensure that electronic copies of original documentation preserve the same content, meaning, and attributes as the original. This process involves second-person verification to compare the electronic copy to the original, a requirement that varies depending on the risk associated with the data. While some guidelines necessitate second-person verification for critical data transcription, others allow for sufficient control of risk through the checks in the Commissioning and Qualification (C&Q) process. The complexity of the copy approval process is further compounded by the need to stay abreast of evolving regulatory standards and guidelines.

Keeping informed about regulatory guidelines.

The ethical standards and regulatory guidelines that govern the industry are constantly evolving, differ nationally and require continuous vigilance and adaptation. In a global, connected digital world, where information is not governed by national borders and needs to be current and up to the minute, companies are faced with complex challenges to meet their business needs, the expectations of their customers but also remain compliant. The most common activity that brings companies into the frame of the UK governing body, the PMCPA, is the interaction with Company news by employees on their social media accounts, accounting for up to half of all cases processed in 2024.

So, getting a copy approved in the pharmaceutical world is quite an adventure. You need to pay close attention to every little detail, follow all the regulatory rules to the letter, and keep up with the constantly changing landscape. It’s like navigating a maze, but you can make it through successfully with the right approach. While advancements such as introducing AQPs and digital tools have helped streamline specific aspects of the process, the inherent complexities remain a significant challenge. By recognising these challenges and implementing best practices, pharmaceutical companies can better navigate the intricacies of copy approval, ensuring compliance, maintaining high standards, and ultimately bringing safe and effective products to market.

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