Post Approval Life Cycle Management

Post Approval Life Cycle Management includes the lifecycle of a product after it has been put on the market. Each organization manufacturing and selling pharmaceutical products, must manage the changes to the Drug Product over time and this process must be managed as it moves through its succession of stages. In the pharmaceutical industry clear guidance is given within Q12 of ICH as well as in commission regulations (EC) No 1084/2003 and (EC) No 1085/2003.

DDReg provides its well established processes for managing

Whether it is Type 1A, 1B, II, variations as defined by EU regulations or CBE, CBE 30, PAS as required by US FDA.

Our services in this area include

  • Gap Analysis and Remediation
  • Response to agency queries/notices on marketed products
  • Variations
  • Advisory on CMC data generation for successful filing
  • Manufacturing Site Transfers
  • Risk Assessments
  • Compliance and renewals.

Other Services

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