Officially launched on July 1, 2008, Regulatory and Quality Solutions LLC (R&Q Solutions), became Western Pennsylvania’s first full-service regulatory and quality engineering firm. President, Maria Fagan, and Vice President, Lisa Casavant, developed the Company with a vision aimed at effectively navigating the complexities of FDA and international regulations. Fagan, Casavant and their team of trained Regulatory and Quality Professionals lead companies down the path to product clearance, resulting in safe, high quality, and effective products being released to the market faster.
Today, the R&Q Solutions team is comprised of approximately 20 engineers and scientists with diverse backgrounds and extensive life science industry experience. The Company’s professionals collectively provide Regulatory and Quality Engineering, Program Management, Design Assurance, Reimbursement Guidance, and Clinical Research Support for the following sectors:
- Start-up Medical Device Specification Developers and Manufacturers
- Established Medical Device Specification Developers and Manufacturers
- Biologics and Combination Product Developers and Manufacturers