Regulatory Gap Analysis and Remediation in the pharmaceutical industry involves evaluating a company’s existing regulatory processes, documentation, and product compliance against current regional and global regulatory requirements. This assessment identifies discrepancies, outdated practices, or non-compliance issues that may pose risks during audits or market expansions. Once gaps are identified, a structured remediation plan is implemented to align with regulatory expectations—covering areas such as labeling, CMC (Chemistry, Manufacturing, and Controls), safety reporting, and dossier updates. This process ensures that pharmaceutical companies maintain continuous compliance, reduce......See More