Headquarters, Bioanalytical & DMPK services
700 Pennsylvania Drive
Exton, PA 19341
T: (610) 232-0100
F: (610) 232-0101

CMC Services & GMP Manufacturing
75 East Uwchlan Avenue
Suite 100
Exton, PA 19341
T: (484) 362-0424

Website: www.Frontagelab.com
Twitter: https://twitter.com/frontagelabs?lang=en
YouTube: https://www.youtube.com/channel/UCJC6J40yb1HdF2XCAURTxfQ
LinkedIn: https://www.linkedin.com/company/frontage-laboratories-inc/

 

Frontage Laboratories, Inc. Your Drug Development Partner

Frontage is a CRO providing integrated, scientifically driven research, analytical, and development services throughout the drug discovery and development process to enable biopharmaceutical companies to achieve their drug development goals.

We offer our clients comprehensive services in analytical testing and formulation development, drug metabolism, and pharmacokinetics (DMPK), bioanalysis, preclinical safety and toxicology, and early phase clinical studies. We have enabled many innovator, generic and consumer health companies of all sizes to file IND, NDA, ANDA, BLA and 505(b)(2) submissions in global markets allowing for successful development of important therapies and products for patients.

We successfully assist clients to advance hundreds of molecules through development to commercial launch in global markets. We are committed to providing rigorous scientific expertise to ensure the highest quality and compliance.

Chemistry, Manufacturing, and Control (CMC) Services

With an outstanding compliance history, the CMC team at Frontage operates under strict adherence to ICH and US FDA GMP guidelines.

Our broad portfolio of services spans drug product development, analysis, and clinical trial materials’ delivery and supply, from preclinical stages through Phase II clinical trials. We support a range of delivery systems including oral solids, topical, and sterile.

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 Services for Small Molecule and Biologics
  • Product Stability Storage and Testing
  • Pre-Formulation and Formulation Development
  • GLP Batch Production and Testing for Preclinical Study
  • GMP Batch Production and Testing for Clinical Study
  • Strong Quality & Compliance Track Record