CERTIFICATIONS
With Veranex, your medical device development pathway is optimized to help you realize your innovation and growth objectives so you can deliver real advances in clinical care that make a difference for patients. Veranex and our legacy companies are certified throughout our business units.
Product Design & Engineering
Our Providence and Plymouth office maintains compliance with 21 CFR part 820.
Clinical Data Services
Veranex Inc., has implemented a strong quality management system and security posture based on the principles of the CIA (Confidentiality, Integrity and Availability) Triad for information security.
Regulatory Affairs & Quality Management
Our consulting and training services on regulatory affairs, quality management and clinical affairs for medical devices and in-vitro diagnostics manufacturers are ISO 9001 and ISO 13485 certified.
Preclinical Services
- Last audits performed by the FDA in 2013 with a positive outcome: No concerns raised by the inspector.
- Strong experience of preclinical studies prepared for FDA and European Notified Bodies.
- All studies are performed according to basic “good practices” which imply high quality standards. Moreover, studies can be performed according to Good Laboratory Practice (21 CFR part 58).
- Veranex Paris Lab has all the authorizations and is fully accredited from the relevant French regulatory institutions in order to practice animal research.
• Veranex Paris Lab has all the authorizations and is fully accredited from the relevant French regulatory institutions in order to practice animal research.
Main Certificates and Guidelines:
- Agrement de la Prefecture
- FDA
- Compacts Regs™ Part 58
- AAALAC International accredited program
Animal Care Policy:
- Fully accredited by AAALAC International.
- Preclinical research is at the level of practicing veterinary medicine: all studies and procedures are supervised by veterinarians (13 DVMs on staff).
- A Senior Veterinarian fully dedicated to animal care.
- Careful Ethics Committee oversight.
