• Product Registration – Preparation, submission, and approval of product registrations for both domestic and international markets.
• Regulatory Compliance – Ensuring all products align with GMP guidelines and meet the conditions of Market Authorization Holders (MAHs).
• Dossier Management – Maintaining and updating Common Technical Document (CTD/eCTD) files, which contain essential scientific and regulatory information for each product.
• Communication with Authorities – Acts as a liaison between Profarma and regulatory authorities
• Lifecycle Management – Handling post-approval modifications, renewals, and variations to keep products aligned with evolving regulatory requirements.
• Pharmacovigilance Support – Collaborating with safety teams to ensure compliance with adverse event reporting and risk management

By staying ahead of global regulatory changes and ensuring strict compliance with all requirements, the Registration Sector plays a crucial role in bringing safe, effective, and high-quality medicines to the market.