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Regulatory Document Articles & Analysis: This-Year
4 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. ...
Specifically, Proregulations helps manufacturers navigate the FDA 510(k) application process through the following steps: Determine Product Classification FDA has different regulatory requirements for medical devices with different risk levels. ...
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 ...
At Proregulations, a company that specializes in assisting with regulatory compliance, we offer U.S. Cosmetics Registration services designed to ensure that cosmetics meet U.S. regulatory requirements, reduce compliance risks, and expedite the product launch process. ...