How can we help?

  • Do you need regulatory strategy or global filing assistance for an IND, NDA, ANDA, IDE, 510k or PMA?
  • Does your quality system need re-vamping or some additional SOPs?
  • Are you getting pressure to audit your third party vendors but don’t have enough time or the expertise?
  • Are you initiating a human study and need IRB support?
  • Do you need high quality and cost effective clinical trial site monitoring?
  • Are you in need of product development guidance and third party vendor oversight?
  • Would you like to understand your target market’s needs to develop a stronger commercialization strategy?