Robust capabilities supporting from Preclinical to Phase I, Phase II CTM, Phase III submission batches, and commercial manufacturing

Clinical Trial Material (CTM) Manufacturing

For R&D, pre-clinical to early-phase clinical trials, partnering with a product development team that prioritizes scalability, quality, and performance is essential. Our experienced formulation scientists specialize in the design and development of robust formulations, finished dosage forms, and scalable manufacturing processes. Suitable to clinical trials to commercialization.

With the state-of-the-art equipment and GMP facility, we engage QbD processes much earlier into R&D to help transition of manufacturing process from bench scale to pilot and large-scale manufacturing with no failures. Our capabilities are supported by GMP-compliant facilities, dedicated GMP manufacturing suites and outstanding quality compliance, allowing us to deliver high-quality drug product for pre-clinicals to Phase-I, II, III and subsequent commercial needs.

Finished Dosage Forms

Frontage’s formulation development and manufacturing team specialized in designing formulations that enable targeted delivery of a drug while ensuring product quality and stability. We support lab scale development to commercial scale production of different dosage forms for IND (Investigational New Drug Application), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) filing, helping from early development through late phase development and regulatory submission. Our facilities are designed with flexibility in mind, allowing us to work with a wide range of dosage forms such as Oral solids, Oral liquids, Semisolids, Sterile (Liquids, Semisolids, LAI) dosage forms while safely handling highly potent compounds in our HiPO suites and DEA-controlled substances Schedule I-V.

Key Capabilities

• Design and development of controlled drug delivery formulations
• GMP manufacturing of clinical trial materials (CTM)
• Support for IND, NDA, and ANDA regulatory filings
• Development of a wide range of finished dosage forms
• Facilities designed for flexibility and rapid project adaptation
• Safe handling of highly potent compounds and DEA-controlled substances

Manufacturing Services –

• Dosage Forms We Manufacture
  • FIH Powder in bottles, Powder in capsules
  • Oral Solid Immediate Release Tablets, Modified Release Tablets, Bi-Layer Tablets, Mini-tabs, Capsules and Liquid Filled Capsules
  • Oral Liquids – Solutions, Gels, Suspensions and Pastes
  • Sterile Injectables – Solutions, Long Acting Injectables (LAI), Nano Particles (SLN), and Nano Emulsions
  • Sterile Ophthalmic- Solutions, Gels, Ointments, Creams
  • Semisolids – Solutions, Gels, Suspensions, Creams, Ointments, Pastes, and Lotions

For early phase clinical trial materials, choose a product development team focused on scalability and performance. Ensure comprehensive product analysis with Frontage’s team of experienced analytical scientists. 

Specialized Capabilities

• Specially designed down flow booths and dedicated area for handling potent compound for occupational exposure levels down to 1μg/m³ (OEB 3-5).
• Negative pressure flexible isolator for handling cytotoxic substances
• DEA licenses for analytical testing and manufacturing (Schedules I-V for analytical and manufacturing) 

Facility

Equipment