Developing and validating more than 300 drug substances and drug product methods each year
Analytical method development and validation is an essential part of the drug development process to ensure the methods are well defined and fit-for-purpose, and the results generated are robust and reliable and that the drug characteristics are in accordance with industry guidelines to allow progression to the next development milestone.
Almac has considerable experience which, coupled with advanced instrumentation, enables the development and validation of efficient, accurate, reliable and robust analytical methods.
Our highly skilled method development scientists have acquired years of experience, working across many types of products, methods and analytical technologies to ensure a successful outcome. Utilizing laboratories equipped with sophisticated analytical instrumentation, we can develop analytical methods suitable for all your needs.
The Almac analytical team have a comprehensive working knowledge of analytical method validation requirements that can be tailored to different phases of clinical development. To ensure methods meet regulatory requirements we follow relevant ICH guidelines such as ICH Q2(R1) or compendial guidance in combination with client-specific protocols. Comprehensive reports are provided upon completion.