Post Approval Life Cycle Management

Maximize Product Value with Expert Pharma Lifecycle Management

Ensuring a product’s success after launch depends on effective post-approval lifecycle management, a crucial process for keeping products on shelves and compliant with ever-evolving regulations. This involves maintaining high standards, and meeting stringent requirements of quality, safety, and accurate labeling. Managing the post-approval lifecycle includes handling any administrative, labeling, or quality changes that could affect the production process or labeling standards, impacting regulatory compliance.

For instance, once marketing authorization (MA) is granted, any further changes in production, labeling, or processes that might influence compliance require filing supplements. These applications notify regulatory authorities, allowing them to assess and authorize changes where necessary. The Q12 ICH guideline and EMA’s EC No. 1085/2003 both provide clear frameworks for managing these essential lifecycle updates.

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: