Biopharmaceutical Research & Product Development Support to Help Sponsors Manage the Best Path Through Development and Commercial Launch

Frontage helps biopharmaceutical organizations advance their research and development efforts with full service offerings– including bioanalysis, preclinical and clinical studies, analytical testing and product development support– spanning discovery stages through late-stage clinical trials. The company also provides turnkey product development, bioequivalence and analytical services to generic and consumer health pharmaceutical companies to support abbreviated new drug application and 505.b.2 application submissions.

Established in New Jersey in 2001, Frontage moved its headquarters and was re-registered in Pennsylvania in 2004. With a 12+ year history of bioanalytical, clinical research and CMC operations, eight state-of-the art research facilities and more than 320 professionals in the US and China, Frontage has enabled biopharmaceutical and generic companies of all sizes to advance hundreds of molecules through clinical development and commercial launch in global markets.

Frontage’s Integrated Services Keep You Out Front

Preclinical Services

  • In vitro ADME studies

  • In vitro metabolism and identification

  • Pharmacokinetic studies

  • Safety pharmacology

Bioanalytical Services

  • LC/MS/MS and GC/MS method development and validation

  • Clinical Biomarker and immunogenicity
  • Biomarker assay development and validation
  • Pharmacokinetic/pharmacodynamic evaluations
  • Streamlined sample management and processing

CMC Services

  • GMP analytical services, including method development and validation

  • Finished product development – immediate and controlled release formulations

  • GMP clinical materials manufacturing – non-sterile and sterile forms

  • GMP API manufacture/organic synthesis of reference standards

  • ICH stability storage and testing services

  • Unknown impurities identification

  • Experienced technical transfer services, scientific and regulatory affairs

Clinical Services

  • Phase I-IIa, 88-bed clinical research unit

  • Bioequivalence, bioavailability, PK/PD evaluations

  • Data management

  • Biostatistics

  • Medical writing

  • Clinical pharmacology consultation, scientific and regulatory affairs