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Meeting your

compliance needs

Bench-top to Market


Niche CRO specializing in developing and maintaining quality systems required by FDA and EU.   Your requirements determine the scope of service.  Ad-hoc, full time or project based.


Areas of Expertise

Blood Products  

Clinical Trials

Computerized Systems

Early Development

GMP Manufacturing


Medical Device

IND & BLA data review





Over 20 years experience.  Available any site worldwide.  Specializing in the unique needs of small and start-up

biotech/ pharma companies.




No job too big or small.  Developing a quality road map based upon your business plan and key milestones.


  • Vendor Audits

  • CMO oversight

  • GCP site audits

  • Documentation

  • Computer validation




 Boston, MA


New Orleans, LA

(Global Availability)



What can I say. Outstanding job on the audit prep and the audit execution. I realize there were long hours and a lot of blood and sweat that went into this process. Your dedication and knowledge gave us an invaluable head of steam as we head into September’s audit. Just a fantastic job on all accounts.


Thank you,


Kevin Hurley



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