Partner with Regis to expedite
your drug to market

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 commercial 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 Managers (PMs) are chemists/engineers with a thorough understanding of Regis' equipment, technology, and capabilities.
  • PMs provide written updates and conference calls (typically weekly) and coordinate with the project internally.
  • PMs handle schedules and information transfer, ensuring that our clients have direct access to the scientists.
  • PMs assure that you receive your contracted deliverables of material, reports, and know how.


  • 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.