SERVICES
LOCAL
Sweden and Nordics
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, act as regulatory manager or project lead for a certain product, or help with selected issues.
regulatory operations
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).
product information translations
mock-up reviews
eCTD dossiers
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 and CMC writers are specialised in the regulatory documents for your applications.
MARKETING / PROMOTIONAL MATERIAL REVIEW - ETHIC'S CODE
eCTD PUBLISHING
The eCTD dossier consists of a variety of documents, including clinical and non-clinical overviews, quality documentation, product information, pharmacovigilance documentation, application form etc. Let us help with the compilation and publishing of the dossier, to make it ready for authority submission.
PHARMACOVIGILANCE
GOOD DISTRIBUTION PRACTICE
brilliant partners
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.
