Developing robust analytical methods is crucial for accurate product characterization and regulatory compliance. Our services include:

• Method Development: Creating precise analytical methods tailored to specific product needs.
• Method Validation: Ensuring methods meet ICH guidelines for accuracy, precision, specificity, and robustness.
• Technology Transfer: Seamless integration of analytical methods into client laboratories or manufacturing sites.

Optimising formulations and manufacturing processes to enhance product performance and stability:

• Pre-formulation Studies: Assessing physicochemical properties to inform formulation strategies.
• Process Optimization: Refining manufacturing processes for scalability and consistency.
• Compatibility Studies: Evaluating interactions between APIs and excipients.

Assessing product stability under various environmental conditions to determine shelf-life and storage requirements:

• ICH-Compliant Stability Testing: Conducting studies under long-term, intermediate, and accelerated conditions.
• Photostability Testing: Evaluating product sensitivity to light exposure.
• On-site Stability Chambers: Utilizing GMP-compliant facilities with controlled temperature and humidity settings.

Identifying potential contaminants from packaging and manufacturing processes to ensure product safety:

• Extractables Studies: Analyzing materials under exaggerated conditions to identify potential leachables.
• Leachables Studies: Monitoring actual product samples over time to detect leachable substances.
• Risk Assessment: Integrating toxicological evaluations to assess patient safety.