Regulatory Support and CTD Writing for Tech Transfer Project

PROJECT OVERVIEW

CAI provided regulatory affairs services for a confidential client in Northern Europe during the site transfer of two sterile injectable products (four strengths) to a new manufacturing facility. The project involved a comprehensive regulatory gap assessment and authoring of Common Technical Document (CTD) Module 3 sections for four injectable products. CAI’s team navigated challenges such as outdated dossiers, recent regulatory requirement changes, and knowledge gaps due to limited support from the sending unit. Through our expertise, CAI successfully prepared the Drug Product CTD documentation package on time, leading to initial Regulatory Agency approval without deficiency letters.

Topics Covered

• Regulatory gap assessment for site transfer
• CTD Module 3 authoring for injectable products
• Compliance with updated regulatory requirements
• Tech transfer support for non-EU manufacturing sites
• Chemistry, Manufacturing, and Controls (CMC) dossier updates
• Cross-functional collaboration in regulatory affairs
• Preparation for regulatory agency inspections