Regis Custom API is a US-based contract development and manufacturing organization (CDMO) focused on the development and manufacture of NCE's (New Chemical Entities). We offer a comprehensive range of drug substance development services including Process Chemistry, Analytical Method Development and Validation, Solid State Chemistry , Micronization, cGMP Manufacturing, Process Validation, and Stability Services.

Over the last 65 years, Regis has a successful history of supporting the development of hundreds of new drug candidates. Many programs have entailed Process Optimization, Process Registration, and Validation. Today, we manufacture drug substance for both clinical use and the commercial market.

Our Mission is to Expedite Drugs to Market

We believe the only way to achieve this goal in such a complex and regulated industry is by having great people working together to provide exceptional service. Our methods are to provide White Glove Service using our Single-Site Strategy to position your program for success.

White Glove Service

At Regis, our attention is focused on the development, cGMP Scale-up, and manufacturing of your drug substance. No distractions. Our Process Chemistry, Engineering, Analytical and Solid State Sciences teams take a fully integrated approach, working side-by-side in the same facility, enabling real-time communication and data collection. You'll receive full access to your dedicated Project Team, which is led by an experienced project manager

Single-Site Strategy for Development and Launch

All of our development and manufacturing of small molecule APIs occur at a single U.S-based site centrally located in the Chicagoland area. Your program will not be qualified in one site and then moved to another off-site location.

• On-site process development teams experienced with your chemistry enables effective technical oversight during critical stages of scale-up (i.e., initial scale-up, additions, splits).
• World-class analytical support teams on-site enables same-day, data-driven decisions managing development risk.
• Using a single site with proven teams capable of delivering drug substance for preclinical, clinical and commercial use virtually eliminates the risk and cost of process transfers. Our unique position of scale, capability and economic alignment make Regis highly attractive for the development and launch of programs with less than metric ton annual demand.

Drug development is fraught with complex challenges. Regis believes transparency and collaboration between the sponsor and CDMO is key to a successful drug substance development program.

Rely on our proven teams with over 65 years of organic synthesis expertise to solve your chemistry challenges and expedite your drug to the clinic and onto the market.View our range of pharma services and capabilities.