Over the years our team has helped numerous Start-Ups and we have real success stories - gene therapy and rare disease Start-Ups that have benefited from our high quality work and successfully filed. While our approach varies, our clients enjoy similar experiences – measurable success. To see what we have done for other companies, please review the list of client projects below.

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Clinical Compliance Gap Assessment

For a client preparing to file an NDA for a gene therapy to treat a rare disease, we conducted an Inspection Readiness Gap Assessment. The outcome from the Assessment included gaps in SOPs, Training and Vendor Activities. As part of a program of “gap closure activities”, we:

  •   Drafted general, clinical and regulatory SOPs
  •   Conducted an assessment of the client’s TMF

Subsequently, the client had a successful inspection and its product was approved, the first of a kind treatment for a rare condition. Anecdotally, we were told that  the Inspector commented on the high quality of the SOPs in place.