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.
Our professional Quality Assurance (QA) and Regulatory Affairs (RA) consulting team has in-depth knowledge of U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations to assist you with your quality and regulatory projects.
We offer the following services:
- Ensures companies meet good manufacturing practice (GMP) standards for pharmaceutical products
- Quality Management System implementation and improvement
- Quality auditing - Subcontractors / Vendors / Suppliers / Manufacturers / Partners' selection and management
- Non-conformities management (deviations, out of specification results, product quality complaints, audit / inspection findings, recalls)
- Continuous improvement (individual projects and CAPA management)
- U.S. / EU Inspection readiness assessment (PAI)
- Draft and Review CMC Sections of IND/NDA/ANDA/BLA
- Validation / Qualification
- QA team training and coaching
- Batch record review and release
- Work with Sponsors and CDMO/CRO to draft Quality Agreements and Service Agreements
- Change control
- Risk analysis
- Gap Analysis
- Storage and shipping
- Facility design