Custom Pharmaceutical Services

At Regis, we pride ourselves in our skill, know-how, and ability to support and expedite small molecule APIs to market. Our full range of on-site services in our CGMP facility, our skilled scientists and dedicated project managers enable us to deliver best in class service while maintaining full possession and control of the entire project from start to finish. You’ll receive the benefits that come from a large CDMO, but at Regis, we pride ourselves in our ability to maintain constant communication and full control throughout the duration of the project.

Trust Regis for your next project and let us help expedite your next drug to market fast.

API Solutions

Partner with Regis to produce your APIs and expedite your discovery to market timeline. We are committed to advancing your APIs from initial development through commercial manufacturing.

IND Enabling Supply

Benefit from over 60 years of drug development experience

Clinical Trial Material

A full service CDMO for all your clinical API needs

Commercial API

Bring your commercial product to a proven commercial supplier.

Orphan & Fast Track

Trust Regis to be your strategic partner for smaller volume API projects.

Contract Development & CGMP Manufacturing

Regis has a clear understanding of organic synthesis and experience in small molecule API manufacturing, supported by a cGMP environment. We have manufactured high value intermediates and APIs under GMP for over 25 years and have the experience to offer and support customized products to suit your needs.

Process Chemistry

Rely on our Ph.D. process chemists to develop your synthetic chemistry route from initial process design and scale up to process validation.

CGMP Scale Up

Choose Regis' CGMP Kilo labs, Reactor suites, Pilot Plant, and/or High Potent Compound Suite to scale up your API or drug substance.

Analytical Development

Take advantage of a full service analytical group that focuses on impurity identification and characterization, method development and validation, fate & purge studies, and more.

Custom CGMP API Manufacturing

Partner with Regis to bring your pre-clinical, clinical, late stage, and commercial APIs from initial process development to process validation and commercial manufacturing.

Project Management

Depend on your proactive advocate with a dedicated Project Manager.

High Potent API Manufacturing

Contract our High Potent Compound Suite for the manufacturing of your HPAPI or drug substance.

Milling

The unique Wet Mill Micronization technology may reduce particle size to 10-20 microns in a contained system with very little yield loss and minimal thermal stress.

Quality Assurance

Benefit from a comprehensive CGMP compliance program.

Quality Control

Guarantee product integrity by relying on Regis' two-shift Quality Control team.

Pharma Services

Regis’ in-house services and highly skilled chemists support your analytical requirements from preclinical through commercialization. Our Quality control services team evaluates product integrity while allowing for instant troubleshooting, and quicker turnaround for your API.

Solid State Chemistry

Reduce drug development timelines and risk with solid state chemistry services from Regis including polymorph, co-crystal, and salt screens and crystallization development.

Stability Services

Support your regulatory submissions and ensure accurate evaluation of quality and more through stability studies and services.

Impurity Services

Select from isolation, characterization, structure elucidation, synthesis scale up for reference standards or markers, and standard qualification services to ensure your drug is safe and timeline is on track.

Fate and Purge

Understanding the origin, clearance, and ultimate fate of impurities is critical to an effective control strategy.

Who We Are

For over 60 years, Regis Technologies, Inc. has partnered with pharmaceutical and biotechnology companies to help expedite their drug candidates to market. We offer a full range of services to support the development of our clients' lead molecules from preclinical and clinical API needs through commercialization. In addition to API development and manufacturing, we also offer an innovative line of proprietary chromatography products sold throughout the world.

Learn more about Regis and our 60 year history.

Who We Are

For 60 years, Regis Technologies, Inc. has partnered with pharmaceutical and biotechnology companies to help expedite drugs to market. Learn more.