Project Management, GMP - Compliance & Regulatory Services

STM Pharma offers services to manage the entire or a part of a project by acting as a 3rd party or in collaboration with or on behalf of its clients.

STM Pharma has deep knowledge  and demonstrated experience in all aspects of GMP-compliance for all phases of CMC product development, quality control, clinical and commercial manufacture. It offers services in establishing new or reviewing and updating existing GMP programs, auditing vendor/CRO//CMO facilities, and assisting in FDA GMP inspections.    

STM Pharma provides guidance / assistance in the drafting and review of common technical documents for CMC submissions, in pre-approval inspections and acts as an interface with the FDA on behalf of its clients.