Pharmaceutical Testing

Pharmaceutical Testing

Regulatory Compliance Guidance

  • The consulting firm offers comprehensive assistance in navigating the complex landscape of pharmaceutical regulations. This includes ensuring that all testing protocols adhere to relevant regulatory standards set forth by agencies such as the FDA (Food and Drug Administration), EMA (European Medicines Agency), and others. They provide expertise in interpreting and implementing regulations, helping clients avoid compliance pitfalls and delays in the approval process.

Method Development and Validation

  • We assists pharmaceutical companies in developing and validating robust testing methods tailored to their specific products. This involves conducting feasibility studies, optimizing analytical procedures, and establishing validation protocols to ensure the accuracy, precision, and reliability of testing results. We may also provide support in transferring methods between laboratories or scaling them up for commercial production.

Quality Control Testing

  • Our services include performing routine quality control testing on pharmaceutical products throughout various stages of development and manufacturing. This involves analyzing samples for potency, purity, identity, and other critical quality attributes using advanced analytical techniques such as chromatography, spectroscopy, and mass spectrometry. Our firm ensures that products meet predefined specifications and comply with regulatory requirements before they are released for distribution.

Stability Studies

  • Our firm conducts stability studies to evaluate the shelf-life and degradation profile of pharmaceutical products under various storage conditions. By monitoring changes in chemical composition and physical properties over time, we help clients determine appropriate storage conditions, expiration dates, and packaging requirements to maintain product efficacy and safety throughout its intended shelf-life.

Analytical Testing Support

  • We offer a wide range of analytical testing services to support pharmaceutical research, development, and manufacturing activities. This includes testing raw materials, intermediates, active pharmaceutical ingredients (APIs), finished dosage forms, and packaging materials for compliance with specifications and regulatory standards. Our experts utilizes state-of-the-art instrumentation and analytical techniques to deliver accurate and reliable test results in a timely manner.

Consultation and Training

  • In addition to technical services, our firm provides consultation and training to help pharmaceutical companies build internal capabilities and expertise in testing and quality assurance. This may involve conducting workshops, seminars, and customized training programs on topics such as analytical method validation, GMP (Good Manufacturing Practice) compliance, data integrity, and risk management. They also offer ongoing support and guidance to address any emerging challenges or issues related to pharmaceutical testing.
  • By offering these comprehensive services, team of our firm enables pharmaceutical companies to ensure the quality, safety, and efficacy of their products while maintaining regulatory compliance and driving continuous improvement in their testing processes.