Analytical development & validation

At Cambrex, we understand that trusted analytical services are an important part of your API project – you can count on our team to provide you with the highest quality analytical support.

Our experienced team of analytical chemists can develop and optimize methods using a wide range of analytical techniques and design validation protocols focused on your project’s own unique requirements.   

Cambrex’s analytical services are based on detailed Standard Operating Procedures (SOPs) and stringent quality assurance practices to comply with cGMP standards.

Whether your analytical requirements are big or small, let our expertise in research and compliance meet your needs.

Drug substance analytical development & validation services

Our analytical services include:

  • Analytical method development and phase appropriate validation
  • ICH stability studies (storage and testing)
  • Reference standard qualification
  • Product release/product retain
  • Route selection
  • Literature/database/patent searches
  • Go/no-go feasibility evaluations of key reaction steps
  • 1-10-gram proof-of-concept lots
  • Toxicology lots for pre-clinical supply
  • Clinical drug substance supply

Get in touch with us

Don’t hesitate to get in touch if you require more information about our analytical services. Our experts are always available to help.

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