Frontage (Corporate Headquarters)
700 Pennsylvania Drive
Exton, PA 19341

T: (610) 232-0100     F: (610) 232-0101
W:
www.frontagelab.com

CMC Services & GMP Manufacturing
75 East Uwchlan Avenue
Suite 100
Exton, PA 19341
T: (610) 232-0100      F: (610) 232-0101

 

AT FRONTAGE, PARTNERSHIP IS WHAT TURNS SERVICES INTO SOLUTIONS

At Frontage, we closely collaborate with pharmaceutical and biotech companies to help them bring promising drug candidates to market. With 14 locations in the US and China, Frontage has been assisting clients in their drug development efforts since 2001. We are committed to providing rigorous scientific expertise to ensure the highest quality and compliance on each project.

Spanning from preclinical through late-stage development, our full-service offerings include DMPK, bioanalysis using 60+ LC-MS/MS instruments, analytical testing, product development, and full biometrics support. Frontage also provides turnkey product development services to generic, innovator and consumer health companies to support IND, NDA, ANDA, and 505(b)(2) submissions.

 Technical Expertise: With 70% of our scientists holding advanced degrees and our depth & breadth of experience, we can solve complex problems

 Highest Standards: We have an unparalleled compliance and quality track record with 32 FDA Inspections across GXP

 Flexibility: We value agile project management, & a commitment to completing projects on time and on budget

 Innovation: Our $40M facility investment and 500+ FTE in USA & China give us the latest equipment and unparalleled access to China

About Our CMC (Chemistry, Manufacturing & Control) Services

With an outstanding compliance history, the CMC team at 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.

Frontage’s CMC portfolio of services spans the entire drug product development of oral solids, topical, and sterile, from proof-of-concept, preclinical through clinical trials and commercialization support. We have extensive experiences in formulation development, analytical method development and validation, technical transfer, and clinical trial materials (CTM) manufacturing, as well as commercial product release and stability testing for US, EU, and Asian markets.

– Analytical Method Development/Validation & Sample Testing
– Formulation Development for IND, NDA & ANDA
– GMP Manufacturing of CTM (Oral Solids, Topical, Sterile
– Commercial Product Release & Stability Testing

 Value to Our Clients

 Integrated: One-stop shop for product development

 Customer Focused: Flexible set up to meet client requirements

 Quick & Responsive: Keep client engaged and timely updates of project status

 Strong Problem-Solving Skills: Help client overcome challenging technical hurdles

 Strong Quality & Compliance Track Record