Prescription Drug
Prescription Drug Testing Services
Your Partner in Prescription Drug Quality & Safety
At Q Laboratories, we partner with pharmaceutical manufacturers, brand owners, and contract development and manufacturing organizations (CDMOs) to ensure prescription drug products meet rigorous standards for safety, efficacy, and regulatory compliance. Our comprehensive testing services support every stage of product development, from raw material qualification and formulation testing to stability studies and finished product release. We help you bring high-quality, compliant medications to market with confidence.
Our Core Expertise
We offer a robust portfolio of services to support your quality and compliance goals:
Microbiological integrity is essential for patient safety and product quality. Our pharmaceutical microbiology services include:
- USP <61> & <62> Microbial Limits Testing
- Antimicrobial Effectiveness Testing (USP <51>)
- Microbial Identification & Characterization
- Environmental Monitoring
- Water System Validation & Routine Monitoring
Reliable analytical data is the foundation of regulatory compliance. Our chemistry team offers:
- Raw Material & API Qualification
- Assay & Potency Testing for Finished Products
- Impurity Profiling & Residual Solvent Analysis
- Method Development & Validation (USP, EP, JP, Custom)
We tailor our methods to your formulation and regulatory strategy, ensuring robust, reproducible results.
Stability testing is critical for determining shelf life, storage conditions, and regulatory approval. Our capabilities include:
- ICH-Compliant Real-Time, Accelerated, and Intermediate Studies
- Packaging Compatibility
- Freeze-Thaw & Stress Condition Evaluations
- Ongoing Stability Monitoring for Commercial Products
Regulatory Frameworks We Support
We help you stay ahead of evolving regulatory expectations with confidence and clarity. Q Laboratories aligns testing programs with key global standards, including:
- FDA cGMP (21 CFR Parts 210 & 211) – U.S. pharmaceutical manufacturing compliance
- ICH Guidelines (Q1-Q10) – International standards for stability, quality, and risk management
- Health Canada Requirements – Support for Canadian market access
- USP, EP, JP Compendial Methods – Harmonized testing for global submissions
