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Overview - Regulatory Gap Analysis

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 affiars services 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.A comprehensive regulatory gap analysis report with the appropriate remediation regulatory strategy provides pharmaceutical companies with insight into the gaps that could hinder regulatory certification Services and product approval.

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.The team provides a regulatory gap analysis report with remediation solutions that address each aspect of the customer’s requirement.

Basics of Regulatory Gap Analysis

A dossier gap analysis in regulatory affairs involves a comprehensive and meticulous review of documents that have been submitted to competent authorities by pharmaceutical companies for their product approval. This helps to identify any missing information that may be required to ensure that pharmaceutical companies are maintaining compliance with regulatory standards. The team at DDReg assesses whether documents, data, or studies are in accordance with the regulatory requirements. This analysis helps to fill any gaps in information to support successful regulatory submissions and subsequent product approvals. Dossier gap analysis is a strategic procedure that helps in mitigating risks of non-compliance, speeds up market approvals, and ultimately ensures adherence to the ever-changing and dynamic regulatory framework.

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