Analytical and Quality Testing Services
We understand that analytical and quality testing are critical to ensuring the safety, efficacy, and compliance of drug products. The testing services at Nuvex Biotech help manufacturers validate drug substances, optimize formulations, and meet global regulatory standards (FDA, EMA, TGA, DRAP, ICH). With a focus on precision, accuracy, and regulatory compliance, we deliver reliable data to help you make informed decisions and meet global quality standards.
Drug Substance and Product Testing
We conduct comprehensive testing of active pharmaceutical ingredients (APIs) and finished products to confirm identity, potency, and stability with our comprehensive testing services:
APIs
testing:
Confirm the chemical structure and composition of your API.
Assay and
potency testing:
Measure the strength and purity of your drug product.
Impurity
profiling:
Identify and quantify impurities to ensure safety and compliance.
SOP Development
Well-defined SOPs (Standard Operating Procedures) are critical for maintaining quality and regulatory compliance. We offer:
Drug Release Testing and Comparative Dissolution
Evaluate the performance of your drug product with advanced release and dissolution testing:
Drug release
testing:
Assess how the drug is released from the dosage form.
Comparative
dissolution studies:
Compare dissolution profiles to reference products.
Bio-relevant
media testing:
Simulate in vivo conditions for more accurate results.
IVIVC (In-Vitro In-Vivo Correlation)
assessments:
Predicting in-vivo drug performance.
Impurity Profiling and Residual Solvent Testing
Impurities and residual solvents impact drug safety and effectiveness. We offer:
ICH-compliant
Impurity profiling:
Detect and characterize known and unknown impurities.
Residual solvent
testing:
Measure residual solvents to meet ICH Q3C guidelines.
Genotoxic impurity
testing:
Ensure compliance with strict regulatory limits.
Microbial and Endotoxin Testing
Ensure the sterility and safety of your drug products with our microbiological testing services:
Microbial limit
testing:
Detect and quantify microbial contamination.
Sterility
testing:
Confirm the absence of viable microorganisms.
Endotoxin
testing:
Measure bacterial endotoxins to ensure safety for injectable products.
Why Choose Our Analytical and
Quality Testing Services?
Advanced instrumentation
& expertise:
Cutting-edge HPLC, GC, FTIR, UV-Vis, and mass spectrometry.
End-to-end
testing solutions:
From raw material qualification to finished product validation.
Customized
testing protocols:
Tailored to formulation-specific and regulatory requirements.
Our Testing
Process
Project
Consultation:
Understand your testing requirements and goals.
Method Development
and Validation:
Develop and validate custom analytical methods (if needed).
Sample
Testing:
Conduct testing using validated methods and state-of-the-art equipment.
Data
Analysis:
Analyze results and prepare comprehensive reports.
Regulatory
Documentation:
Provide documentation for regulatory submissions.
Ongoing
Support:
Offer continuous support for quality assurance and compliance.