About

CRO Focused on Early Phase Drug Development

Frontage Labs is a contract research organization who helps pharmaceutical and biotech companies bring promising drug candidates to market. We specialize in early phase drug development, providing bioanalytical labs, discovery stage and preclinical drug metabolism and pharmacokinetics, Phase I/IIa clinical studies and product development support. Frontage has enabled biopharmaceutical and generic companies of all sizes to advance hundreds of molecules through clinical development and commercial launch in global markets.  

A comprehensive portfolio of CMC product development services includes organic synthesis, pharmaceutical formulation development, GMP analytical testing and GMP clinical trial material manufacturing, for all types of drug candidates ranging from novel, early phase projects to generic-equivalent and consumer care medications. Over the last ten years, Frontage developed oral solid, semi-solid, liquid and sterile dosage forms that have been evaluated in clinical research programs and commercialized in the US, EU and Asian markets by its clients.

Established as a one-person consulting organization in New Jersey in 2001, Frontage moved its headquarters to Pennsylvania in 2004, and introduced new services during its thirteen-year history. Today, more than 300 staff conduct evaluations, studies and tests across eight research facilities in the US and China.

Frontage’s Integrated Services Keep You Out Front


DMPK Services

  • In vitro ADME studies
  • In vivo ADME studies
  • Metabolite identification
  • Non-GLP bioanalytical studies
  • Radiolabeled studies
  • Metabolites in safety testing (MIST) for clinical compounds

 

 

 

 

Bioanalytical Labs for Small and Large Molecules

  • Method development, transfer and validation

  • Sample analysis
  • Clinical biomarker and immunogenicity
  • Biomarker assay development and validation
  • Pharmacokinetic/pharmacodynamic evaluations

CMC Services

  • GMP API manufacture/organic synthesis of reference standards
  • Pharmaceutical product formulation development
  • GMP clinical materials manufacturing – non-sterile and sterile forms
  • GMP analytical services, including method development and validation

Clinical Services

  • Phase I-IIa early phase clinical development services

  • Bioequivalence, bioavailability, PK/PD evaluations

  • Clinical data management to support Phase I-IV studies

  • Biostatistics to support Phase I-IV studies

  • Medical writing to support Phase I-IV studies