Analytical development

Reliable analytical development and regulatory compliance to accelerate your CMC success. At Quality Assistance, we help you develop robust analytical methods to ensure the quality of your drug candidates.

Get advice from an expert

As a trusted CRO exclusively dedicated to analytical sciences, we combine scientific excellence, regulatory understanding and operational efficiency within our fully integrated single-site model. This approach ensures consistency, traceability and seamless communication throughout your analytical development journey.

Our expert scientists develop and adapt analytical methods to fit your molecule’s unique profile and development stage, helping you move faster from your lab to patients.

Key analytical services

Method development and optimisation

We design new analytical methods from scratch or optimise existing ones using Analytical Quality by Design (AQbD) principles, ensuring robustness, method capability, reproducibility and effective risk control.

Method validation

We verify and validate method performance according to your development stage and in full compliance with EMA, FDA and ICH guidelines.

Method transfer

We perform seamless method transfer to or from your laboratories, with full documentation and analyst training when required.

Documentation

We prepare complete and comprehensive documentation deliverables including Standard Operating Procedures (SOPs), protocols and detailed analytical reports, ready for regulatory submissions and inspections.

Statistical support

We provide advanced statistical expertise, including Design of Experiments (DoE) during development and robustness assessment, total error approach for method validation and control chart implementation for continuous monitoring of method performance.

Why does it matter?

Our analytical development expertise helps you:

Our analytical development services rely on cutting-edge technologies/techniques. Discover how these complementary platforms reinforce our analytical capabilities.

Related techniques

Modalities we cover

Your strategic partner

Looking for a reliable partner to design, validate and transfer your analytical methods with precision and compliance, and streamline your CMC development?

Contact our experts to discuss how we can strengthen your analytical strategy.

Speak with an analytical expert