Quality Compliance

Our Client: A small pharma company engaged Safis to establish Quality Systems.

Being a start up, the Client did not have sufficient personnel for Quality Systems and needed direction. The Safis team created SOPs for the following: clinical, non-clinical, manufacturer, quality, and regulatory. The team helped write, approve, sign and train the personnel. The training program was created and files have been maintained.

Safis was involved in the review and release of product batch records, as well was the development and validation of for protocols being reviewed and approved.

Quality systems put in place by Safisí team include the following: audit scheduling program for vendors, storage facilities, drug production manufacturers, drug supplying manufacturers, analytical labs, packaging, CROs, data management facilities, and distribution facilities. These Quality Systems have been provided for the Client in the US as well as in Europe.

Safis assisted with the creating certificate of analysis. The team 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.