GMP Custom Manufacturing

Regis plays a vital role in the pharmaceutical industry by developing commercially viable chemical processes and producing active pharmaceutical ingredients (APIs) for preclinical, clinical, and small to medium scale commercial use under current Good Manufacturing Practices (GMPs). We help our customers expedite the discovery-to-market timeline by servicing all of their needs at one facility. Regis can advance your project from the small-scale development stage through final validation and commercial manufacturing.

Tour our facility

For virtual companies, Regis can serve as the entire process research and manufacturing division. For companies with their own production facilities, Regis provides GMP manufacturing capabilities or additional reactor capacity without the capital expense. In both cases, Regis is an important partner in our customers' drug development processes, and the Regis team thrives on the challenges that these partnerships bring. If the scale eventually exceeds our capacity, we assist customers in transferring the technology to a supplier with larger equipment. Regis offers:

• EXPERIENCE
  • Proven track record with pharmaceutical companies of all sizes
  • Veteran production, R&D, validation and analytical teams
• COMMITMENT TO QUALITY
  • Strict adherence to GMPs
  • Modern in-house Quality Control laboratory
  • Quality Assurance department ensures accurate documentation and material tracking
• VERSATILITY
  • Scale: 1g-1+metric tons
  • Wide variety of Reactions
  • Equipment size ranging from kilo hoods to 500 gallon reactors
  • 150-gallon Hastelloy reactor for low temperature work (down to -85° C)
• FLEXIBILITY
  • Two shift operation for production, QC and QA
  • Flexible reactor schedule