Preformulation and Preclinical Support
We can perform preformulation, reverse engineering, and excipient compatibility studies for generics. For NDAs, starting with a lead drug candidate, we perform a series of preformulation experiments to verify the physiochemical properties of the molecule by evaluating pKa, pH solubility and stability, excipient compatibility, and crystal structure. We can then develop an appropriate formulation and manufacture GLP batches for safety and toxicology studies.
Formulation Development for Generics and NCEs
Our formulation development team has hands-on experience on the following:
- Oral Solids (IR and MP), and oral liquids
- Injectables
- Semisolids and topicals
- Ophthalmics
- Nasal
- Early phase and first-in-human formulations
- Solubility enhancement
- API-in-bottles and API-in-capsules
- Blend-in-bottles and Blend-in-capsules
- Liquid-filled capsules
- Placebo matching
Analytical Services
We provide a full range of analytical testing services.
- Analytical Method Development, Validation and Transfer
- ICH Stability Testing and Storage
- IVRT and IVPT Testing
- API and Finished Product Testing
- Impurity Identification
- Extractable and Leachable Studies
- Elemental Impurities
- Nitrosamines
- Microbial Testing
- QC Release &Commercial Stability
Specialized Capabilities
- Potent compound handling for occupational exposure levels down to 1μg/m3 (or Safebridge Category III)
- DEA licenses (Schedules I-V for analytical and manufacturing)
Quality Assured
With an excellent compliance history, Frontage operates under strict adherence to ICH and US FDA GMP guidelines. Our facilities and processes undergo routine audits and inspections from sponsors and regulatory authorities. Our SOPs, while robust, have the flexibility to accommodate a variety of protocols, templates and reporting formats according to client requirements.
The Frontage Commitment
For more than 20 years, we have earned a reputation for collaboration, responsiveness, and the ability to customize services and deliverables that are aligned with the needs of our clients.
