Regulatory Gap Analysis - DDReg Pharma

A gap analysis is a regulatory review process that identifies data gaps in the technical documentation required for preparing the dossier & the application before applying for regulatory approval. Gap analysis is also carried out for in-market products to identify the gaps between market requirements vs products’ filed & authorized specifications. It can also be an identification of differences between activities and expectations in standard operating procedures. Thus, gap analysis, as interpreted and understood in different ways, is a comparative evaluation between current practices and regulatory guidelines.

The best way to successfully get a product cleared by the regulators or experience a passing inspection from them is to always be prepared for inspections. Preparation for situations includes continuous regulatory gap analysis will help improve any possible deficiencies that are present within standard procedure implementation or applicable guidelines.

DDReg offers comprehensive gap analyses services including review of customers’ current product specs, labels and other technical documentation related to:

  • Initial Submission,
  • Dossier Extension of Registered Products,
  • Registered Dossier of Legacy Drug products
  • Lifecycle Management

A remediation strategy is developed and tailored according to the customer’s requirements once all gaps have been identified.