Medical Devices

Medical devices encompass a wide range of instruments, machines, implants, and software used in healthcare for diagnosis, treatment, monitoring, and prevention of diseases and conditions.
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Our services:
  • 510k Applications
  • Audits
  • Virtual manufacturer inspections
  • ISO 13485:2016
  • 21 CFR part 820 Quality Systems
  • Combination devices
  • Gap analysis and mock FDA inspections
  • Class III implantable devices

Pharmaceuticals

Pharmaceuticals are medicinal drugs or medications designed to diagnose, treat, cure, or prevent diseases, disorders, or medical conditions in humans or animals.

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Our services:
  • New Drug and Biological License Applications
  • 503B Compounding
  • ​API manufacturing    
  • Audits
  • Virtual manufacturer inspections
  • 21 CFR part 210 and 211 Quality Systems
  • Sterile manufacturing
  • Cellular therapies
  • ​Gap analysis and mock FDA inspections
  • ​CLIA and CAP compliance

Food & Nutritional Supplements

Nutritional supplements are products formulated to provide vitamins, minerals, or other nutrients that may be lacking in a person’s diet. 

Our services:
  • Audits
  • Virtual manufacturer inspections
  • 21 CFR part 111 Quality Systems
  • ​Gap analysis
  • Ensure compliance with local and international regulatory requirements, such as FDA, TGA, GHA, Health Canada, NSF, NASC, and EFSA guidelines.
  • Third-Party Certifications: Seek and ensure certifications like GMP, NSF, or USP to demonstrate quality and safety.