Over the years our team has helped numerous Start-Ups and we have real success stories - gene therapy and other rare disease companies that have benefited from our high quality work and successfully filed their products. 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 rare disease client preparing for an NDA, we conducted an Inspection Readiness Gap Assessment. The outcome from the Gap Analysis included gaps in SOPs, Training and Vendor Activities. As part of a program of “gap closure activities”  we drafted SOPs in Clinical, Regulatory, Manufacturing as well as General SOPs and we conducted an assessment of the client’s TMF.

As a result of our work, the client had a successful inspection and got it’s product approved, the first of a kind treatment for a rare condition. In review of the SOPs, the Inspector commented on the high quality of the SOPs in place.