Assessments & Gap Analysis

The main objective of doing the Regulatory Assessment / Gap Analysis in the pharmaceutical industries is to identify the gap between the regulatory requirements governing the market authorizations and post approval compliance and the current status of the Drug Product. This helps provide the client with insight into under development & in-market Drug Products that have room for improvement.

DDReg has loads of experience in carrying out the market specific regulatory assessments/ Gap Analysis of technical data/product dossiers for their 1) readiness to file for grant of MA and/or 2) compliance status while in-market

Our services in this area include

  • Regulatory Assessment & Gap Analysis of Drug Product
  • Remediation Plan for Gaps observed in DMF and Drug Product Reviews

Other Services


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