Regulatory Agency Inspection preparation & Quality Oversight
- Area: Canada, Saskatchewan
- Project Type: QA
About this Project
OBJECTIVE
Preparation for regulatory agency inspection services
SERVICES
Our client, a research foundation in Saskatchewan, brought PSC Biotech on for Quality Assurance services. The client was seeking GLP lab accreditation to aid in their therapeutic development programs. PSC Biotech was able to oversee, arrange, conduct, and report on audits of cGMP facilities, nonclinical systems.
PSC Biotech is responsible for overseeing the implementation of a pharmaceutical quality program to support the client’s agency inspection preparation. This process involved: reviewing: reviewing procedures and systems, checking for consistency with appropriate practices, assisting in the preparing/revising SOPs.
Project Success
Related Projects
20 Years & Counting of CQV Services
Cleaning Validation & Decommissioning Project
PSC hired a validation specialist who stayed within budget and the time frame set originally by PSC and the client.
Sterile Fill/Finish Laboratory Facilities CQV Project
The operations performed included: Filling, Parts Preparation, Formulation, Filling, Process Support Systems and Cleaning.
How Can We Help You?