Compliance Documentation Articles & Analysis
3 news found
The expert team at Proregulations is skilled at preparing the modules of the MAA document in compliance with EMA guidelines, as well as conducting a comprehensive review and gap analysis of the document. ...
Proregulations provides personalized ASMF compliance services that cover not only the preparation and submission of technical documents, but also effective communication with regulators. ...
Drug Master File (DMF) Preparation l APIs DMF preparation l Excipient DMF preparation l Packaging materials DMF preparation Documents Preparation and Submission l ANDA registration information list organization l Writing and organizing all documents required for ANDA l Review documents, product labeling and instructions l Submission of eCTD ...