Regulatory affairs is a term that includes a lot. But we dare say we cover most of what is included in the term as from the late development phase and onwards, for pharma products. We have highly experienced regulatory specialists who can act as your regulatory affairs department, or help with selected issues. For early development regulatory affairs, we collaborate with our brilliant colleagues within the CTR group.
Chemistry, manufacturing and control data, also known as the quality documentation, is as important and extensive for all types of products and applications. We can help you with the writing of module 3 and the quality overall summary, with guideline interpretations and variations classifications. We can also help you in the communication with and coordination of contract manufacturing and development organisations (CMOs/CDOs).
The writing of regulatory reports and summaries that both conveys the applicant’s message and are in line with applicable regulations and guidelines is a skill of it’s own. Our medical writers are specialised in the regulatory documents for your applications.
The eCTD dossier consists of a variety of documents, including clinical and non-clinical overviews, quality documentation, product information, pharmacovigilance documentation etc. We cover the writing of all of them. And we also do the compilation and publishing of the dossier.
RegFile is a member of the brilliant consultancy group Center for Translational Research – CTR
Within the group we can normally find any complementary expertise needed.