Custom CGMP 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 through process validation and commercial manufacturing. Partner with Regis to bring your pre-clinical, clinical, late stage, and commercial APIs to the next level.

Process Expertise

Development Chemistry

Regis' Process Development team has expertise and experience in process design, development, transfer, and optimization. This team of Ph.D. chemists has an average of over 20 years experience.

Learn more about our Process Development team here.

Timely and Thorough Communication

Project Management

Trust a Project Manager (PM) throughout your entire project at Regis, from executed proposal to release of the final batch. Regis PMs have a thorough understanding of what it takes to deliver your project. PMs coordinate the work required with the Project Team internally and ensure that our clients have direct access to our scientists through written technical updates, conference calls (typically weekly), and individual conversations. PMs manage the project scope, maintain the project schedules, tracks the project budgets while remaining in continual communication with our clients.

Learn more about our Project Management team and philosophy.

Dedication to Compliance

Quality Assurance

Regis Technologies’ Quality Assurance (QA) team reviewing binder of custom API CGMP SOPs Regis maintains a CGMP compliant organization with a fully staffed, two-shift Quality Assurance team. Fundamental to a compliant facility, all Regis employees undergo CGMP training. Regis’ positive track record with the FDA and other foreign regulatory agencies assures that your manufacturing will be compliant with all regulations. Routinely FDA inspected, we proudly boast of zero Form 483s 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 CGMP batches from 100 g to 5 kg.

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

For your high potent APIs, commission Regis' new High Potent Compound Suite for development and CGMP production.

Read more about our CGMP Scale Up capabilities.

Pharma Services

Analytical Support

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

  • Method Development & Transfer
  • Method Validation
  • Impurity Identification
  • Qualification of Reference Standards and Markers
  • Fate & Purge Studies
  • Quality Control
  • ICH Stability Studies

Services may be contracted with your ongoing project or as stand alone pharma services. Learn more about our Analytical 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. Trust our expertise, and rely on our proven track record of successful partnerships with pharmaceutical companies of all sizes.

Contact us today for more information, or to get started on your project now.

Process Expertise

Development Chemistry

Regis' Process Development team has expertise and experience in process design, development, transfer, and optimization. This team of Ph.D. chemists has an average of over 20 years experience.

Learn more about our Process Development team here.

Your Dedicated Liaison

Project Management

Trust in a dedicated Project Manager (PM) throughout your entire timeline, from executed proposal to release of the final batch. Regis PMs are scientists with a thorough understanding of our equipment, technology, and capabilities. PMs provide written updates and conference calls (typically weekly) and coordinate with the Project Team 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.

Dedication to Compliance

Quality Assurance

Regis Technologies’ Quality Assurance (QA) team reviewing binder of custom API CGMP SOPs Regis maintains a CGMP compliant organization with a fully staffed, two-shift Quality Assurance team. Fundamental to a compliant facility, all Regis employees undergo CGMP training. Regis’ positive track record with the FDA and other foreign regulatory agencies assures that your manufacturing will be compliant with all regulations. Routinely FDA inspected, we proudly boast of zero Form 483s 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 CGMP batches from 100 g to 5 kg.

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

For your high potent APIs, commission Regis' new High Potent Compound Suite for development and CGMP production.

Read more about our CGMP Scale Up capabilities.

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

Pharma Services

Analytical Support

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

  • Method Development & Transfer
  • Method Validation
  • Impurity Identification
  • Qualification of Reference Standards and Markers
  • Fate & Purge Studies
  • Quality Control
  • ICH Stability Studies

Services may be contracted with your ongoing project or as stand alone pharma services. Learn more about our Analytical 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 our Business Development Executive team for more information and to get started on your project now.

Request a Quote