Method Development & Validation
Looking for method development and validation support in compliance with GMP and ICH Q2?
Quercus Laboratory has the necessary QC equipment and expertise to support you in your validation challenges.
Please do not hesitate to contact us for more information on our method development and validation services.
Well-defined methods
Robust and reliable results.
Method development and validation are essential to the drug development process to ensure the methods are well-defined and fit-for-purpose, and the results are robust and reliable.
We develop scientifically sound and cost-effective analytical methods in cooperation with our customers:
- Analytical method development
- Transfer of existing methods
- Method Adaptation and Optimization
- Method Validation according to ICH guidelines
Meeting regulatory requirements
Keeping abreast of all relevant guidelines
To ensure that the methods meet regulatory requirements, we follow relevant ICH guidelines such as ICH Q2(R1) or compendial guidelines in combination with client-specific protocols.
After validation of the analytical procedure, the methods are ready for transfer to the contract provider, if requested.
This is done in accordance with EU-GMP Chapter 6, where an interlaboratory reproducibility test is performed within a co-validation between two sites or a revalidation.
Comprehensive reports can be provided upon specific customer request or our regulatory team can assist in submitting the report to the relevant authorities.