Analytical Method Validation
Are you looking for analytical method development and validation support in compliance with GMP and ICH Q2?
Quercus Laboratory – part of the QbD Group – has the necessary QC equipment and expertise to support you in your validation challenges.
Don’t hesitate to contact us for more information about our analytical method validation services. We’d be happy to help!
What is Analytical Method Validation ?
Both regulators and quality assurance agencies require that medicinal product analysis results be obtained using validated methods.
The purpose of validating an analytical procedure is to demonstrate that it is suitable for its intended purpose.
The principles are described in ICH Q2 and manufacturers of medicinal products must adhere to this chapter when medicinal products are analyzed and released.
Why QbD Group?
A knowledgeable partner like Quercus – part of the QbD Group – can provide analytical method validation in accordance with ICH Q2.
Quercus holds a GMP license and an ISO 17025 certificate and is audited by the Belgian FAGG.
We have the necessary experts to write your validation reports for submission to the authorities.
If the analytical method needs to be optimized or developed before validation, QbD is the right partner to help you.
Outsourcing your validation
If you outsource your validation to Quercus, you will always have a clear picture of the costs in advance.
As soon as we receive your analysis request, you will get a detailed quote and a lead time for reporting the analysis results.
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service for all your validation challenges.