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.

PROCESS EXPERTISE

DEVELOPMENT CHEMISTRY

Development Chemistry via Regis's Flow Chemistry System

Regis' Process Development team has expertise and experience in process transfer, development, and optimization. The process team has an average of over 20 years experience.

Learn more about our Process Reseach team here.

YOUR DEDICATED LIAISON

PROJECT MANAGEMENT

Trust in a dedicated Project Manager (PM) throughout your entire timeline, from proposal to final batch. Regis PMs are chemists/engineers with a thorough understanding of our equipment, technology, and capabilities. PMs provide written updates and conference calls (typically weekly) and coordinate with the project internally. They handle schedules and information transfer, ensuring that our clients have direct access to our scientists. A dedicated Project Manager assures that you receive your contracted deliverables of material, reports, and know how.

Learn more about our Project Management team and philosophy.

Utilize a Dedicated Project Manager during your entire API timeline.

DEDICATION TO COMPLIANCE

QUALITY ASSURANCE

Regis' two-shift Quality Assurance Division maintains our GMP compliant organization.

Regis maintains a GMP compliant organization with a fully staffed, two-shift Quality Assurance team. 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 most recent audit here. Regis welcomes your audit of our quality systems.

Read more about our Quality Assurance team.

PRECLINICAL TO COMMERCIAL

cGMP SCALE UP

Advance your candidate for early scale up, preclinical studies, and through Phase 1 clinical studies by scaling up in Regis' cGMP Kilo Labs. Regis can scale up and manufacture initial GMP batches from 100g to 2kg.

Transition easily through Phase 2 and all the way to commercial manufacturing with Regis' cGMP Reactor suites capable of 100 kg per batch.

For your potent APIs, commission Regis' new Potent Compound Suite for the development and cGMP production up to about one kilogram per batch.

Read more about our cGMP Scale Up capabilities.

View a list of example synthesis reactions and our available processing equipment.

cGMP Scale Up at Regis for Potent Compounds

PHARMA SERVICES

ANALYTICAL SUPPORT

Trust in Analytical Support for your Active Pharmaceutical Ingredient

Rely on an expert Analytical Method Development team when trusting your active pharmaceutical ingredient to Regis. Our AMD team will provide services such as: 

  • Method Development & Transfer
  • Method Validation
  • Quality Control
  • ICH Stability Studies

Services can be contracted with your ongoing project or as standalone pharma services. Learn more about our Analytical Method Development services.

RELY ON 60 YEARS OF EXPERIENCE

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.

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

HAVE A CHEMISTRY NEED? REQUEST A QUOTE.