Quality variations
Let us share some great regulatory tips from Läkemedelsverket (Swedish Medical Products Agency). They have published a list of well-thought-out tips directly from their quality
Meny
Let us share some great regulatory tips from Läkemedelsverket (Swedish Medical Products Agency). They have published a list of well-thought-out tips directly from their quality
We handle regulatory procedures, both new applications and variations, and create and publish eCTD. If you prefer, we are happy to act as your entire regulatory department.
We write and compile the documentation for regulatory applications for medicines. The pharmaceutical, preclinical and clinical documentation as well as pharmacovigilance documentation, product information and other administrative documentation.
Our small but well-chosen group of consultants have extensive experience within their respective areas, from both pharmaceutical industry and regulatory authority, and keep ourselves constantly updated.
RegFile AB
Eklundshovsvägen 1G,
752 37 Uppsala, Sweden
info@regfile.se
