Frontage Laboratories boasts a world-class team of highly experienced scientists and state-of-the-art infrastructure. Drawing on extensive global expertise, our team swiftly navigates the complexities of drug product and drug substance development to deliver tailored, fully integrated solutions across the entire pharmaceutical lifecycle.

Drug Product Services & Manufacturing

Operating out of dedicated R&D labs and state-of-the-art GMP manufacturing suites, we provide comprehensive formulation development and finished dosage form manufacturing supporting IND-enabling services, NDA submissions, and generic ANDA filings. Our capabilities span from lab-scale pre-clinical batches through Phase I–III Clinical Trial Materials (CTM), up to registration batches and commercial production.

• Sterile Dosage Forms:  We specialize in aseptic fill-finish manufacturing for both small- and large-molecule products, utilizing semi-automated and fully automated sterile filling lines within ISO 5 qualified cleanroom environments. Our sterile capabilities include solutions, suspensions, intravitreal injectables, nanoparticles/emulsions, and long-acting injectable (LAI), with support for vials, cartridges, prefilled syringes (PFS), and bags.
• OSD & Topical Dosage Forms:  Our advanced R&D formulation and manufacturing platforms support a broad range of oral solid dosage (OSD) and topical products, including immediate- and modified-release tablets, bilayer tablets, mini-tabs, capsules with coated pellets and neat API filled, and liquid-filled capsules with capsule binding. We also offer expertise in oral liquid formulations such as solutions, suspensions, gels, and pastes, as well as a full range of topical and semisolid products including creams, ointments, lotions, and gels, packaged in bottles and tubes.
• Sterile Ophthalmic Products:  We provide specialized development and manufacturing capabilities for sterile ophthalmic solutions, gels, creams, and ointments. Our infrastructure includes controlled low-humidity storage conditions designed to support semi-permeable packaging systems, including ophthalmic 3-piece bottles and tubes.
• High-Potency Handling (HiPo Suites): Engineered down-flow booths and negative-pressure flexible isolators ensure the safe handling of highly potent compounds with occupational exposure bands down to 0.1 μg/m³ (OEB 3-5).
• Controlled Substances: We hold active DEA licenses (Schedules I-V) across both manufacturing and analytical testing.

Drug Substance (API) & Intermediates

We provide robust process chemistry development alongside custom chemical synthesis, building a solid foundation from initial scale-up to global tech transfers (including IND M3, CTA, and DMF preparation).

• Process Chemistry & Route Optimization: Expertise in route design, process optimization, and polymorph screening, including salt, co-crystal, and prodrug screening.
• Synthesis & Batch Manufacture: Custom manufacture of intermediates and regulatory starting materials (RSMs). We deliver both non-GMP batches for IND-enabling toxicology studies and GMP-compliant batches to support early-phase clinical trials.

Comprehensive Analytical Testing & Stability Services

Equipped with state-of-the-art instrumentation, our analytical services provide comprehensive testing for drug substances and developmental or commercial drug products.

• Comprehensive Capabilities: Specializing in phase-specific method development and validation, routine GMP product release and stability testing, extractables & leachables (E/L) studies, elemental impurity analysis by ICP-MS or ICP-OES, and trace-level genotoxic impurity analysis via high-resolution LC-MS/MS.
• Microbiology: Full-panel USP monograph testing for drug products and raw materials, including microbial limits, sterility, preservative effectiveness, and endotoxin testing, as well as environmental monitoring for drug product manufacturing facilities.
• In Vitro Drug Product Release: Comparative dissolution (USP testing) for solid-dose products, drug release testing for nanoemulsions, and In Vitro Release Testing (IVRT) / In Vitro Permeation Testing (IVPT) for topicals and ophthalmic products.
• ICH Stability Storage: Over 10,000 cubic feet of continuous, 24/7 electronically monitored storage chambers supporting all standard ICH conditions, WHO Zone IVb (hot/humid), photo-stability testing, and specialized low-temperature/low-humidity monitoring.

Uncompromising Quality Assurance & Global Regulatory Compliance

With a stellar compliance history, Frontage operates under strict adherence to ICH and US FDA GMP guidelines. Our continuous, proven track record is validated by routine client audits and successful inspections from major global regulatory authorities, including the US FDA, EU QP Certification, and the China FDA (NMPA).

For over 25 years, Frontage Laboratories has built its reputation on deep collaboration, scientific excellence, and a highly responsive approach to customizing deliverables that precisely align with our sponsors’ strategic pipelines.