GMP Synthesis Services

 
Custom API Manufacturing

Expedite your discovery-to-market timeline by partnering with Regis Technologies to produce your Active Pharmaceutical Ingredients (APIs). 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 pre-clinical, clinical, and commercial API's to the next level.

 

Development Chemistry

  • Expertise & experience in process transfer, development & optimization
  • Critical process parameter studies

cGMP Scale-up

  • cGMP Kilo labs for early scale up, preclinical and Phase 1
  • cGMP Reactor suites for Phase 2 to commercia manufacturing to >100 kg/batch
  • Potent Compound Suite--development and cGMP production to ~1 kg
  • Detailed equipment list

Analytical Support

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. Routinely FDA inspected, we proudly boast of zero Form 483's on multiple audits; read about our 2014 audit here.  
  • Regis welcomes your audit of our quality systems.

Project Management

  • Dedicated project management team comprised of experienced chemists and chemical engineers assures ongoing customer communication and that your project is kept on schedule with no surprises.

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.

 

Contact Us

Email Wayne Nowicki, Director of Business Development, for more information or to start your project now.