Regulatory Writing – Module 3
For a drug product to meet the rigorous standards required by healthcare regulators, it is essential not just to document programs and processes, but to document them in the right way.
At MOD3 Pharma, our intimate knowledge of the regulatory landscape allied to our experience of the written submission process – specifically for Module 3 – ensures partners can meet the expectations of healthcare authorities including the US Food & Drug Administration (FDA), the European Medicines Agency (EMA) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
From our unique vantage point, we have a view across both clinical development and cGMP manufacture. And through both internal and client-sponsored programs this has given us rich insight into the breadth and depth of information required for a successful submission.
Our regulatory intelligence is augmented by highly robust processes and procedures that have been designed with compliance in mind. With over 300 standard operating procedures (SOPs) in place at our cGMP facility, we are ready to design and document development programs that are fully aligned to the standards set by regulators.
