Venture Capital Recommendation Saves the Day for Scuffling Startup
A general partner in a well-respected venture capital (VC) firm was referred to Richman Chemical by a fellow colleague within the private equity industry. The VC’s funded biotech startup was facing the pressure of a make or break deadline for keeping the firm afloat. The startup had an Investigational New Drug (IND) that had already been submitted to the FDA; however, the technical package contained vague data and there were no satisfactory cGMP reference standards. With time at a severe premium, the partner contacted Richman Chemical directly and connected the biotech firm with the right external resource to save the project.
Utilizing its 25 years of industry experience, Richman Chemical completed a comprehensive evaluation of the technical package and identified the weak links. Under Richman Chemical's direction, clinical trial batches were prepared alongside reference standard preparation and validation. Additional tests were performed for the end formulation, concurrent with stability testing of the active compound. A dialogue was established with therapeutic and delivery mechanism experts to ensure a product suitable for clinical trials. The end result was a successful FDA review and a grant of fast track status, and an influx of additional funding for the biotech startup.