We can help you find your way through the complex and highly regulated landscape of the Pharmaceutical Industry
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 quite a burden on your time and resources when you don’t have the expertise in this area. National and sometimes, even regional differences, are not always easy to identify and comprehend.
At MMD, our network of highly experienced professionals will provide expertise and help guide you to achieve your desired quality and regulatory requirements. We understand that not two quality or regulatory scenarios are the same, hence we will work with you to find a solution to your regulatory and quality conundrums that is not only simple, efficient, and cost effective but also compliant – a tough ask indeed – we know!
Whether it is a review / audit of your quality systems or writing SOPs or even putting together a brand-new quality system, we can help.
We can provide assistance with pre-market and post-market regulatory activities from developing registration documents to compliance with post registration requirements.
Do you find yourself scratching your head or feeling lost and overwhelmed with quality and regulatory requirements? Wondering how to comply with all of the stringent requirements? Stuck with Pharmaceutical quality and regulatory challenges? Worried about the quality of your pharmaceutical operations?
Case Studies
Case Study 1
Scenario
Quality: An Asian company starting their operations in Australia contacted us to confirm if their Pharmaceutical Quality Systems were compliant with the local regulations and requirements. We did a thorough review and audit of their processes, identified gaps and worked with them to address the same so that they are ready for a Health Authority inspection.