Managing the post-approval life cycle of a product is an essential component to sustaining it on shelves. It is necessary to maintain compliance with regulations related to quality, safety, and labelling. Post-approval life cycle management is an integral part of maintaining the quality and safety of a product. This includes any changes (administrative, labelling or quality) that may impact upon process, production or labeling and hence affects compliance with regulatory requirements. For example, if a MA has been received but there are subsequent changes to be made in respect to process, production or labelling impacting compliance then applications called supplements should be filed which will notify regulators accordingly so they can evaluate whether the change needs authorization. Clear guidelines on post-approval life cycle management have been laid down by Q12 ICH guideline as well as EC No 1085/2003 set forth by EMA.
Regulatory services pertaining to Post Approval Life Cycle Management at DDReg are delivered by a team of highly skilled regulatory and post-approval specialists. We provide our 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.
DDReg’s post-approval life cycle management services include:
- Variations pertaining to
- Labelling Change Notifications/approvals
- Artwork changes
- Any Change related to manufacturing process
- Marketing Authorization Holder (MAH) transfers
- Certification of Suitability (CEP) updates/new CEPs
- Monograph updates i.e., Compliance to Pharmacopoeia
- Shelf-life extension/reduction