A startup did not have sufficient personnel or experience to develop a quality system. The Safis team created and implemented SOPs for clinical, non-clinical, manufacturing, quality, and regulatory areas. The team also created and implemented a quality training program, including creating materials and maintaining files.
Safis was involved in validating protocols for, and implementing, the review and release of product batch records.
The Safis team established a quality system covering audit scheduling program for vendors, storage facilities, drug production manufacturers, drug supplying manufacturers, analytical labs, packaging, CROs, data management facilities, and distribution facilities for locations in the U.S. and Europe.
Safis assisted with creating the certificate of analysis, and created a plan for clinical site auditing, a quality agreement between the client and vendors, and CMC document management.
Safis provides on-going support of the client’s Quality Systems services.