We specialize in analytical services for both small molecules and biologics

The service area includes method development, validation and transfer for product development and clinical trial materials (CTM) manufacturing , as well as routine GMP product release and stability testing. Our well established microbiology lab can provide full spectrum USP microbiology testing for both drug substance and drug product. We have established state-of-the-art instrumentation and expertise to support Extractables & Leachable, Nitrosamine Testing, Residual solvents, Unknown Impurity identifications.

Our labs have gone through multiple FDA inspections and we have DEA licenses for testing controlled substances (Schedule I-V)  

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. 

In Vitro Release Testing (IVRT) and 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  
• Establish total cumulative amount (AMT) and maximum flux (Jmax)) profiles for a topical drug product using IVPT.
• 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 versus innovator drugs(e.g., RLDs) comparison 
  • Pre- and post-change formulations comparison  
  • Quality control/lot release, lot-to-lot variability  
  • Formulation optimization  
  • Analytical method development and validation  
• Compliant to FDA-PSG, EMEA Annexes I and II
• State-of-the-art fully automatic 24 cell Logan instrumentation
• 72 cell Franz diffusion systems
• Hanson systems
• Sotax USP- IV

Dissolution Testing

Our facility is equipped with state-of-the-art USP Apparatus I (Basket) and Apparatus II (Paddle) systems, designed to provide the critical kinetic data needed for IVIVC, stability, and quality control.

Our Capabilities Include:

• Comparative Dissolution (f2 testing): To support manufacturing changes or SUPAC filings.
• Media Screening: Evaluation of various pH levels and surfactants for poorly soluble drugs.
• Stability Monitoring: Ensuring your product maintains its release profile over its shelf life.

USP Apparatus I (Basket): Ideally suited for capsules, beads, and formulations that float or require high surface area exposure.

USP Apparatus II (Paddle): The industry standard for tablets, disintegrating dosages, and modified-release products.

Stability Management Services  

Frontage offers a variety of storage conditions for test samples to meet the demands of drug development requirements in different markets throughout the world. We have the expertise and equipment to handle large-scale studies and specialized studies alike.  

• Over 10,000 cubic feet of storage 
  • 4 walk-in large rooms 8’x20’x8’; 6 walk-in 8’x8’x8’ rooms; 6 reach-in chambers 
• Typical ICH storage conditions & WHO (Zone IVb hot/higher humidity) 
  • 25°C/60%RH, 30°C/65%RH, 40°C/75%RH, 30°C/75%RH 
• Low Humidity for Semi Permeable Containers (Ophthalmic Products) 
  • 5°C, 25°C/40%RH, 40°C/25%RH 
• Low Temperature for Parenteral & Lyophilized Products 
  • -70°C, -20°C, 5°C, 25°C/60%RH  
• ICH compliant temperature-controlled photo-stability chamber 
• 24/7 e-monitoring system/Emergency backup power generator for continuous operations