cGMP - Quality Assurance & 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.

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