For one Fortune 500 biotech company with a missing parts problem, RCA created a process that included build lists, SOPs with embedded color pictures, 3-D exploded diagrams for all set ups, and GMP documentation to show the process was in control. In short, RCA took a crisis and turned it into a best practice.
Biologics are a result of some of the most advanced and progressive biomedical research. According to the FDA, “Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources—human, animal, or microorganism—and may be produced by biotechnology methods and other cutting-edge technologies.”
Regulatory Compliance Associates® Inc. can assist you in ensuring the quality of your biologics during its entire lifecycle. From pre-market to post-market reviews, inspection, and compliance, we can shepherd your biologics through design, production, labeling, promotion, production, and testing.
Our Biologics services include:
- Regulatory Strategy
- Product Development support
- Clinical Development Support
- Outsourced Regulatory Support
- Due Diligence