Analytical Method Development for Non-Sterile Products

At PCI, our in-house state-of-the-art analytical laboratories combined with our highly skilled and experienced team of scientists seamlessly support our manufacturing capabilities, delivering the development and validation of efficient, accurate, reliable and robust analytical methods.

Method development and method validation are critical steps in the pharmaceutical drug manufacturing process to ensure the quality, safety, and efficacy of drug products. These processes are essential in establishing robust and reliable analytical methods for use across the development to launch cycle.

Method development focuses on designing and optimizing analytical techniques to accurately measure the quality and quantity of active pharmaceutical ingredients (APIs) and other components in a drug formulation and plays a vital role in optimizing the manufacturing process. By developing efficient analytical methods, we are able to monitor and control critical process parameters.

The validation of methods ensures reliable and reproducible results, minimizing the risk of erroneous data and guaranteeing the integrity of the manufacturing process.

The ultimate goal of pharmaceutical manufacturing is to produce safe and effective drugs. Method development and validation contribute to this goal by ensuring that drug products are accurately tested for their composition, purity, and potency, minimizing risk and meet necessary quality standards.

Our dedicated team of specialists will be happy to discuss any of our Sterile Manufacturing Services with you. Contact us on +1 215-613-3600 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com