We specialize in analytical method development, validation and transfer for product development and clinical trial materials (CTM) manufacturing support, as well as commercial product release and stability testing.
Our services are designed to help sponsors throughout the drug development process in their effort to fully characterize drug substances, developmental formulations and commercial drug products.
- Method development, validation and transfer
- Unknown impurity identification
- Extractable and leachable studies
- GMP API and finished product release testing
- GMP commerical product stability testing and storage
- GLP dosing sample analysis
- DEA license for testing controlled substances (Schedule I-V)
In Vitro Release Testing (IVRT) & In Vitro Permeation Testing (IVPT)
Frontage offers comprehensive IVRT and IVPT testing services, from preclinical formulation assessments to early phase human studies, for topical products.
An extensive menu of in vitro studies helps you:
- Develop and select the optimal formulation
- Assess the effect of penetration enhancers/modifiers on percutaneous absorption
- Develop and validate novel analytical and sample processing methods for optimized sensitivity and selectivity
- Develop, validate, and conduct in vitro release test (IVRT) assays for FDA SUPAC-SS submissions
- Provide compliance for GLP studies and analytical method validations
- Our IVRT method development and validation services for topical dosage forms such as ointments, creams, lotions, gels and liquid include:
- Generic (e.g., RLDs) versus innovator drugs comparison
- Pre- and post-change formulations comparison
- Quality control/lot release, lot-to-lot variability
- Formulation optimization
- Analytical method development and validation
CGMP Analytical Testing for Biologics
Biologics or biopharmaceuticals are inherently more complex than small-molecule drugs. You need the right team to help you. Frontage has expertise and state of the art instrumentation necessary for the analytical method development, validation and transfer for complex biopharmaceutical compounds.
- Reference standard qualification
- In-depth structural elucidation
- Comparability or Biosimilarity
- Forced degradation
- Support of formulation development