We can help you find your way through the complex and highly regulated landscape of the Pharmaceutical Industry and Medical Device Industries.

Anyone who has ever worked in the Pharmaceutical industry will agree that it is one of the most highly regulated industries in the world. Navigating through complex legislation, regulations, directives, guidelines, best practices, and codes of practice can appear daunting and cumbersome. National and sometimes, even regional differences, are not always easy to comprehend.

MMD staff have an up-to-date and in-depth expertise in medicines and medical devices allowing you confidence that you will have expert advice and will have the highest chance of successfully navigating these increasingly regulated industries, in Australia, the UK and Europe. With a profound understanding of the multiple registration pathways and approvals in Australia, the MHRA and the EMA, including the new MDR changes, we understand your products, your development, the strengths and weakness of a dossier and how to translate this knowledge to a successful plan and registration.

Whether it be prescription biologicals, biological medicines or small molecules, an OTC medicine, or a drug-device combination or a high-level medical device requiring clinical expertise, we have the team to meet your needs in effecting fast and efficient registrations.

MMD offers strategic regulatory advice, advanced technical writing, responses to consultations to influence your environment, submissions to regulators, meeting support with regulators and government, responses to expert advisory committees and submission of appeals for an adverse regulatory outcome or on-call support to assist you and your team if and when you require.

MMD has the skills and expertise to take on and deliver regulatory outcomes that are a step further than what you may have hoped for, delivering optimised outcomes in faster timeframes, contact us now for an initial discussion.