Commercial API

The Right Fit Partner for Low-Volume, High-Value API Supply

Regis is a proven leader in bringing development projects to market having advanced numerous projects from IND stage through pharmaceutical development, validation, launch, and actively supports ongoing commercial manufacturing. Regis’ unique blend of commercial experience and manufacturing scale (up to 2000 L vessels) is a strategic fit for companies and projects that do not need several metrics tons a year. At Regis you will benefit from our skill and experience while receiving the personalized attention you deserve.

Approved Commercial APIs Marketed in over 50 Countries

CDMOs must possess the necessary skill to successfully navigate global regulatory requirements in order to support a project from development to commercial. To receive marketing approval for commercial manufacturing of a drug product, the synthetic process for producing active ingredients must be clearly understood, validated and documented as such to demonstrate compliance to various CGMP and global regulatory standards. Beyond compliance effective operations, project management, supply chain, quality assurance, regulatory affairs, and change management are necessary to maintain supply chain continuity. Regis is proven with decades of commercial API experience supporting globally marketed products and will confidently deliver your commercial API.

Regulatory – Regis’ brings value to your project with our decades of experience supporting regulatory applications (NDAs and DMFs). Regis’ performs the roles of Agent and Manufacturer for multiple active Drug Master Files and has successfully responded directly with global regulatory authorities. Having experience with CMC filings in over 50 different countries on several distinct new chemical entities, Regis brings valuable insight for when collaborating on PDUFA responses or taking a more active role in your CMC regulatory strategy.

Supply Chain Continuity – Regis proactively manages its products and processes. Each step of the process is carefully reviewed including facilities, materials, and equipment and mitigating strategies are applied based on the likelihood and impact to understand the risk and collaborate on mitigating strategies. Such strategies include dual sourcing key intermediates from geographically diverse sources, building safety stocks, campaigning, redundant capacity, engineering controls, process monitoring or administrative controls. Regis includes its clients and collaborates for the best paths forward individualized to each product to ensure uninterrupted supply.

A Decade of Clean Compliance history (no 483s)

Quality – Regis has a proven track record of compliance evidenced by multiple consecutive regulatory inspections without finding (NAI classification). Our Quality Assurance team stays to ahead of evolving CGMP requirements around the globe. Commercial API production is closely monitored and controlled to established conditions documented in batch procedures ensuring critical process parameters are met. Statistical tools and methodologies (i.e. SQC, SPC) are employed throughout the process to identify trends and take preventative actions. Potential changes or deviations can be quickly reviewed against product history to understand and manage against potential impact to quality.

Regis is committed to maintaining a relationship built on trust with customers and global regulatory authorities.

Approved Commercial APIs Marketed in over 50 Countries

CDMOs must possess the necessary skill to successfully navigate global regulatory requirements in order to support a project from development to commercial. To receive marketing approval for commercial manufacturing of a drug product, the synthetic process for producing active ingredients must be clearly understood, validated and documented as such to demonstrate compliance to various CGMP and global regulatory standards. Beyond compliance effective operations, project management, supply chain, quality assurance, regulatory affairs, and change management are necessary to maintain supply chain continuity. Regis is proven with decades of commercial API experience supporting globally marketed products and will confidently deliver your commercial API.

Regulatory – Regis’ brings value to your project with our decades of experience supporting regulatory applications (NDAs and DMFs). Regis’ performs the roles of Agent and Manufacturer for multiple active Drug Master Files and has successfully responded directly with global regulatory authorities. Having experience with CMC filings in over 50 different countries on several distinct new chemical entities, Regis brings valuable insight for when collaborating on PDUFA responses or taking a more active role in your CMC regulatory strategy.

Supply Chain Continuity – Regis proactively manages its products and processes. Each step of the process is carefully reviewed including facilities, materials, and equipment and mitigating strategies are applied based on the likelihood and impact to understand the risk and collaborate on mitigating strategies. Such strategies include dual sourcing key intermediates from geographically diverse sources, building safety stocks, campaigning, redundant capacity, engineering controls, process monitoring or administrative controls. Regis includes its clients and collaborates for the best paths forward individualized to each product to ensure uninterrupted supply.

A Decade of Clean Compliance history (no 483s)

Quality – Regis has a proven track record of compliance evidenced by multiple consecutive regulatory inspections without finding (NAI classification). Our Quality Assurance team stays to ahead of evolving CGMP requirements around the globe. Commercial API production is closely monitored and controlled to established conditions documented in batch procedures ensuring critical process parameters are met. Statistical tools and methodologies (i.e. SQC, SPC) are employed throughout the process to identify trends and take preventative actions. Potential changes or deviations can be quickly reviewed against product history to understand and manage against potential impact to quality.

Regis is committed to maintaining a relationship built on trust with customers and global regulatory authorities.

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