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 

Product Development

Broad portfolio supporting preclinical through Phase II clinical trial material (CTM) manufacturing.

Analytical Services

Complete characterization of your drugs. We specialize in analytical services for both small molecules and biologics  

Biologics Cell & Gene Therapy

Our extensive services offer a ‘one-stop-shop’ experience

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.