We’re widely recognized within the life science industry and global regulatory agencies for our ability to help companies successfully resolve complex regulatory challenges. By mining regulatory intelligence, we continuously evaluate the FDA’s current thinking and leverage thought leadership networks to advocate for our medical device, pharmaceutical, biologics, combination product, and compounding pharmacy clients.
Our breadth of expertise in the Medical Device industry is globally renowned and in demand. Our services include regulatory affairs, assessments and audits, agency response, preparation and remediation, and strategic consulting on new product development, lifecycles, and staffing support.
Our background and experience in the Pharmaceutical industry has helped thousands of companies meet regulatory, compliance, quality assurance, and remediation challenges, in addition to their strategic consulting needs.
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 levels of expertise and leadership. The following case study illustrates...Read More
Small or emerging life science organizations often put off hiring quality executives, exposing the company to risk or worse. Other...Read More
RCA Designs a Shipping Validation Study for a Pharmaceutical Company with Two API Manufacturers Located in Europe
A pharmaceutical start-up with a novel drug approached RCA to design its shipping validation study. RCA developed multiple studies based...Read More