CMC-Product Development & Manufacturing

Our portfolio of Product Development and CMC services spans from pre-clinical through formulation development, analytical, CTM manufacturing, and commercial product support.

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CMC-Product Development & Manufacturing

Offering a broad portfolio supporting preclinical through Phase II trials.

We are a full spectrum CDMO with Formulation, Analytical, and Novel Drug Delivery platforms supporting NCE, 505b(2), and ANDA products from pre-clinical through Phase III Clinical Trial Material (CTM) manufacturing. 

Our portfolio of services span pre-formulation, drug product formulation development, analytical method development and validation, GLP batches, GMP clinical trial materials, scale-up, pilot, and pivotal/registration batches, and commercial manufacturing (to be ready Q3 2024). 

Core Services Capabilities 

Specialized Capabilities

  • Potent compound handling for occupational exposure levels down to 1μg/m3 (or Safebridge Category III) 

  • DEA licenses (Schedules I-V for analytical and manufacturing) 

Quality Assured

With an excellent compliance history, Frontage operates under strict adherence to ICH and US FDA GMP guidelines. Our facilities and processes undergo routine audits and inspections from sponsors and regulatory authorities.

Our SOPs, while robust, have the flexibility to accommodate a variety of protocols, templates and reporting formats according to client requirements. 

The Frontage Commitment 

For more than 20 years, we have earned a reputation for collaboration, responsiveness, and the ability to customize services and deliverables that are aligned with the needs of our clients.

Commercial Manufacturing:
Whats Coming in Q3 2024

Our new state of the art facility with over 46K sq ft includes a number of manufacturing suites

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