EMERGENCY! Need a Novel Chemical Excipient-STAT!

A medical device company was in need of a crucial excipient for a new product in advanced clinical trials. The excipient was a novel organic compound formulated with the actual medical device to provide the desired properties. The company, however, had a BIG problem: they made medical devices and had no expertise in the synthesis of organic chemicals!

Soon after contacting Richman Chemical, the company's fears were alleviated. We were able to evaluate some rudimentary technology for preparing the molecule provided by the company, and then take it from there.. We collectively optimized the synthetic process, scaled it up to the appropriate manufacturing size, and developed an FDA-approved, cGMP manufacturing protocol for successfully making the critical material-all within a span of approximately 18 months.

As a result of our cooperative efforts, enough material was prepared to satisfy anticipated market needs in anticipation of commercial approval. When the new product became commercial shortly thereafter-and thanks to our accelerated project management initiative, supply was able to meet demand for the exciting new medical device.