GMP/ISO 13485 Compliance

Let us help you achieve GMP and ISO 13485 compliance.

We can provide a broad range of services from validation protocols to establishing the required documents to meet ISO13485 and QSR compliance.

As part of our services, we can assist you implement the following documentations and systems throughout your facility:

  1. Raw material testing and control
  2. Manufacturing SOPs and product history records
  3. Equipment and facilities validation protocols
  4. Process validation
  5. Quality Control procedures and release criteria generation
  6. Customer complaint handling and recall procedures
  7. Quality Systems Manual
  8. Labeling and quarantine SOPs
  9. Equipment SOPs
  10. Quality audit procedures
  11. Design validation and verification
  12. Sterility validation and verification procedures based on FDA recognized procedures.

We also provide a variety of technical and regulatory services to manufacturers of medical devices, diagnostics, food, cosmetics, and drugs including:

For additional information, email or call 908-875-7466.