Every pharmaceutical organization must manage the post-approval changes to the Drug Product over time as it moves through its life cycle. In the pharmaceutical industry, clear guidance is given within Q12 of ICH and EC No 1085/2003 Of EMA are some of the global guidelines on post-approval life cycle management.
DDReg provides its well-established processes for managing post approval changes whether it is Type 1A, 1B, II, variations as defined by EU regulations or CBE, CBE 30, PAS as required by US FDA.
Gap Analysis and Remediation
Response to agency queries/notices on marketed products
DDReg is a global pharmaceutical consulting firm that deals with regulatory services for leading pharmaceutical companies. We are trusted partner of leading pharmaceutical companies to manage their regulatory affairs portfolio.