Orphan & Fast Track

The number of targeted medicines and products serving rare and neglected diseases has grown and continues to rise. Regulatory pathways such as Orphan, Fast Track, or Breakthrough designations offer alternative pathways to market. While these smaller markets do not require large volumes, they do still require the skill, experience, and quality making finding the right CDMO important. Additionally, these projects require a personalized approach and should operate on a scale that is attractive to all parties to inspire a collaborative partnership.

At Regis, we understand the challenges and have built an organization specializing in bringing these small-volume, high-value new chemical entities to market. Our facility, organization, and quality systems possess the experience and agility to support your product and our mission of expediting drugs to market. Regis has successfully supported several NDAs and continues to produce commercial APIs used in global commercially marketed products. We will work with you to develop and execute a tailored plan designed for you for your APIs needs.

Agile - US Based, Privately Held Company

Size - GMP Multi-Purpose Facility at 5-2000L Scale

Proven - Over 60 Years Clinical and Commercial Manufacturing

Quality - A Decade of Clean FDA Compliance (no 483s)

At Regis, we understand the challenges and have built an organization specializing in bringing these small-volume, high-value new chemical entities to market. Our facility, organization, and quality systems possess the experience and agility to support your product and our mission of expediting drugs to market. Regis has successfully supported several NDAs and continues to produce commercial APIs used in global commercially marketed products. We will work with you to develop and execute a tailored plan designed for you for your APIs needs.

Agile - US Based, Privately Held Company

Size - GMP Multi-Purpose Facility at 5-2000L Scale

Proven - Over 60 Years Clinical and Commercial Manufacturing

Quality - A Decade of Clean FDA Compliance (no 483s)

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

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