At Pharma Addon, we are committed to delivering R&D Analytical Services that adhere to the principles of Quality by Design. Our approach ensures that analytical methods are developed, validated and transferred using scientifically driven strategies to achieve reliable and compliant results.
Our experienced team collaborates with clients to develop robust and efficient analytical methods
tailored to their specific needs. By considering critical quality attributes (CQAs) and employing QbD
principles, we ensure that the developed methods are reliable, accurate, and optimized for the
intended purpose.
We perform comprehensive method validation studies to demonstrate the suitability, accuracy, precision, specificity, and robustness of the developed analytical methods. Following QbD principles, we design validation protocols that encompass the necessary parameters and acceptance criteria to ensure compliance with regulatory requirements.
We specialize in the seamless transfer of analytical methods between laboratories, whether it involves method transfer from development to QC/QA departments or from one site to another. By following a well-defined protocol and utilizing QbD principles, we ensure that the transferred methods maintain their integrity and performance across different environments.
Our expertise extends to cleaning method validation, where we establish scientifically sound
procedures to verify the effectiveness of cleaning processes and demonstrate the absence of residue
or contaminants on equipment surfaces. Following QbD principles, we design cleaning validation
protocols that consider critical process parameters and appropriate analytical techniques.
