Resources

A recently registered 503B Sterile Outsourcing Facility was facing serious enforcement action from the FDA. Under RCA's guidance, the company became one of the first outsourcing facilities to remediate FDA's...

Background A biological drug development company based in Europe came to RCA as their facility expansion was under construction. A team of RCA experts engaged in guiding this company through...

Client Challenge A European based company engaged in biosimilar drug development requested RCA to develop a regulatory strategy for seeking approval for their drug in the US and EU. The...

A global medical device manufacture needed to meet the May 26, 2021 EU MDR compliance deadline. Collecting the reference documentation from suppliers was a challenge due to their geographic location....

In today’s competitive business environment, emerging life science companies run lean, particularly in terms of personnel. However, the complexities of the quality (QA) function in medical devices require the highest...

A pharmaceutical start-up with a novel drug approached RCA to design its shipping validation study. RCA developed multiple studies based on the company's complex transportation, product stability, and packaging needs....