Compliance Documentation Articles & Analysis
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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. ...
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 ...