With deep expertise in ICH-GCP, EU-CTR, and global regulatory standards, we help organizations build robust, efficient, and compliant documentation practices that support operational integrity and long-term quality success.
From initial setup to ongoing management, we provide solutions that ensure your Trial Master File meets all regulatory standards efficiently.
Tailored creation of TMF Plans, optimization of TMF Reference Model usage, and thorough GAP analyses to maintain inspection-ready documentation. eTMF Implementation and Support