Reglera, LLC

Reglera is a leading organization specializing in quality and regulatory consulting and process outsourcing. Reglera focuses on two primary industries: medical devices and human cellular and tissue products. Since 1994, Reglera has been helping tissue and medical device companies navigate the regulatory maze through its expertise and understanding of regulatory and quality systems requirements.

Based in Lakewood, CO, Reglera is recognized as one of the largest and fastest growing regulatory consulting and outsourcing companies in the world. With more than 100 employees worldwide, and an unmatched group of strategic partners, Reglera is uniquely positioned to provide companies with products and services covering a wide variety of technical and support areas. Reglera fixed bid pricing approach is unique to Reglera industry and provides significant benefits to Reglera clients.

Whether you are developing a new product, improving an existing product, need assistance with the FDA, or are simply trying to comply with the myriad of regulation and standards, Reglera's products and services will accelerate your success and profitability. If the right regulatory partner for your company is one that not only advises, but also specializes in implementation and results, choose Reglera. Reglera combination of regulatory expertise and operational knowledge will accelerate your products to market and ensure compliance and operational efficiency. In addition, all of Reglera products and services come with the guarantee that if you receive any FDA observations, Reglera will respond to the FDA and correct the issue and at no charge to you.