Navigating complex regulatory environments is critical for pharmaceutical companies. Our service in Regulatory Compliance & Annex 16 Support aids organizations in meeting stringent EU GMP requirements. Key elements of this service include:

• Supply Chain Mapping: We help you develop a comprehensive map of your supply chain, covering all critical elements—from drug substances and critical excipients to intermediates and finished products.
• Documentation Accuracy: Our experts work with you to ensure all documented evidence is complete, up-to-date, and fully compliant with Annex 16 of the EU GMP Guide. This includes detailed records of transportation, storage, handling facilities, and all associated activities.
• Licensing and Compliance: We assess every facility involved in the supply chain to verify that they hold the proper licenses for their activities, safeguarding product integrity from production to the marketplace.

This service simplifies the certification process for release to market and establishes a solid foundation of trust with regulatory authorities.