Analytical Development

Whether you have some in-house testing capabilities or you’re looking for end-to-end outsourcing, it’s critical to build an analytical support program that carefully balances three needs: technical expertise, understanding of regulatory guidelines and compliance with cGMP standards. Each phase in a product’s lifecycle has unique analytical considerations, so it’s imperative to design a phase-appropriate method validation strategy.

At Cambrex, our experienced team of API analytical development specialists can develop and optimize methods using a wide range of analytical techniques and design validation protocols focused on your project’s own unique requirements. Our analytical method development services are based on detailed Standard Operating Procedures (SOPs) and stringent quality assurance practices to comply with cGMP standards. Plus, our collaborative approach ensures that we fully understand your molecule and all of its complex and unique testing challenges. We maintain continuous contact over the life of the project, with the same senior-level scientist available to interact with your team, even if testing spans several Cambrex departments and sites.

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