GMP / ISO 13485 compliance

We take immense pride in providing consulting services to numerous of clients,
helping them achieve their ISO certification goals.

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:

  • Documentation for process manufacturing and quality control testing written to comply with QSR/GMP/ISO 13485 and GLP.
  • Validation protocols written and performed for processes and equipment.
  • Manufacturing process evaluation of drug, biologics, diagnostic reagents and products. Our past experience in manufacturing provides practical assistance in production scale up and process problem-solving.
  • GMP and ISO 13485 audits performed to identify areas in which compliance may be weak or lacking. A report is submitted with recommendations for improvement.
  • GMP refresher training

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


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We'd love to hear from you! If you are in need of ISO Family of Standards, Regulatory or Cybersecurity Compliance Support Services, call us at 908.875.7466 or fill out and submit this form. A member of our team will get back to you shortly.

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