Frontage Laboratories

Frontage Laboratories is a global CRO and CDMO with sites in North America, Asia Pacific and Europe. It takes lead candidates from discovery through IND-enabling studies to first-in-human and Phase II, with bioanalytical, analytical and central lab testing alongside formulation and clinical trial material manufacturing.

Preclinical Development and IND-Enabling

• Advance candidates through bioanalysis, biomarker assay services, DMPK and ADME studies, in vitro pharmacology, drug-drug interaction and transporter studies, and pharmacokinetics or PK/PD modeling. Its bioanalytical team has over 450 scientists in the USA, Canada, Europe and China.
• Plan and execute toxicology and nonclinical safety work, including GLP toxicology, genetic toxicology, specialized toxicology, safety pharmacology, pathology, histology, and tissue analysis. Frontage also supports integrated IND-enabling programs with toxicology, safety pharmacology, and analytical or bioanalytical elements.

Clinical Pharmacology and Laboratory Operations

• Prepare for first-in-human and Phase I-IIa development through clinical pharmacology support and bioavailability or bioequivalence studies; Frontage reports more than 25 years of Phase I-IIa study execution experience.
• Manage clinical trial laboratory workflows through CAP-accredited and CLIA-certified central lab services, clinical trial bioanalytical and biomarker testing, specialty testing, clinical pathology and histology, genomics including microbiome sequencing and metagenomics, and molecular laboratory services. Its central lab support includes kit design, specimen shipment management, temperature-controlled logistics, reconciliation, and archival tracking.

CDMO, Analytical and Manufacturing Workflows

• Move drug candidates from formulation and analytical development into manufacturing through Frontage’s full-spectrum CDMO services for NCE, 505(b)(2), and ANDA products, supporting preclinical through Phase III clinical trial material manufacturing.
• Develop and test drug products and substances through formulation optimization, analytical method development, validation and transfer, GMP release and stability testing, sterile and complex injectable manufacturing, aseptic fill-finish, oral solid dose manufacturing, and small-molecule API manufacturing.

Discovery, Biometrics and Regulatory Support

• Evaluate and refine discovery programs through Frontage Global Drug Discovery Services (GDDS): integrated drug discovery, medicinal chemistry, assay development, compound screening, disease biology and mechanism-of-action studies, in vitro and in vivo pharmacology, and oncology xenograft models.
• Prepare clinical and regulatory deliverables through clinical data management, database programming and edit checks, biostatistics, statistical analysis plans, CDISC SDTM and ADaM datasets, submission datasets, tables, listings and figures, IND documents, regulatory strategy, regulatory writing, and aggregate safety reports.

Best Fit

• Biopharmaceutical teams seeking one CRO/CDMO partner from discovery and IND-enabling work through first-in-human studies, clinical laboratory operations, biometrics and manufacturing.
• Programs requiring specialized analytical and laboratory support, including cell and gene therapy product testing, extractables and leachables studies, sterility and microbiology testing, biomarker assay development, or clinical sample logistics.