GMP Synthesis Services

Expedite your discovery-to-market timeline by partnering with Regis Technologies to produce your Active Pharmaceutical Ingredients (APIs) and intermediates. We are committed to advancing your projects from initial process development, scale-up development through final validation and commercial manufacturing. Partner with Regis to bring your regulatory starting material, pre-clinical, phase I-III and commercial API to market.

 Development Chemistry

  • Begin your synthesis in our newly constructed GMP development labs. 
  • In these labs, we synthesize at scales from less than one gram, to 12L.

 Scale-up

  • We have scaled up hundreds of compounds from less than a gram to the multi kilo level and up to the 100+ kilogram scale
  • Regis will work with you as the project scales up from 50L flasks up to 2000L reactors in individual suites.

GMP Production

  • Our facility is run according to current Good Manufacturing Practices (cGMP) and is routinely inspected by the FDA. Regis has manufactured high value intermediates and APIs under GMP for over 20 years.

 Analytical Method Development

  • Skilled in the transference, development, and validation of analytical methods, our experienced scientists work together to meet your complex analytical needs.

Quality Control

  • Regis maintains a modern, in-house QC department responsible for the release of raw materials, in process and final release testing. Regis offers additional QC services including fully compliant ICH stability studies.

 Quality Assurance

  • Regis maintains a GMP compliant organization with a fully staffed, two shift Quality Assurance Division. Fundamental to a compliant facility, all Regis employees undergo GMP training. Regis’ positive track record with the FDA and other foreign regulatory agencies assures that your manufacturing will be compliant with regulations.  Our last FDA inspection in 2012 had no '483 observations.  Regis welcomes your audit of our quality systems.

Project Management

  • Full time project managers, all with bench and analytical chemistry experience, act as the customer’s internal champion steering projects through Regis in an efficient, professional manner.

Experience

  • Leverage our decades of experience to develop your commercially viable chemical processes. Make use of our veteran production, R&D, validation and analytical teams. Rely with confidence on our proven track record for pharmaceutical companies of all sizes.