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Post Approval Life Cycle Management

Post approval Life Cycle Management (PLM) includes the lifecycle of a product once it has been launched in the market. It is about the maintenance of the product in the market in compliance to the regulation pertaining to its quality, safety and labelling. These maintenance activities provide little competitive advantage but are critically important to maintain sales. We, at DDReg, provide comprehensive post approval maintenance regulatory services to our clients

We help clients in

  • Change Control Management
  • Regulatory intervention and Guidance
  • Renewals
  • Risk Assessment/Analysis
  • Variation Applications – Regulatory Guidance & Compilations ofs
  • Site Transfers
  • Other Types of Variations
  • Regulatory Gap Analysis & Remediation
  • Compliance Dossiers
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