Method Validation

Ensuring reliable and compliant analytical procedures

Method validation is an essential process to confirm that analytical procedures meet regulatory requirements and deliver accurate, reproducible results.

At QbD Group, we ensure your methods align with global standards, such as ICH Q2(R1) and compendial guidelines, while tailoring them to your specific needs. Our expertise and robust validation processes provide confidence in the reliability and compliance of your analytical methods.

Get in touch

What is method validation?

Method validation is a systematic process of evaluating analytical methods to ensure they consistently deliver reliable and accurate results for their intended purpose. This process verifies that methods meet predefined criteria and are suitable for regulatory submission and routine use. Key aspects of method validation include:

Regulatory Alignment: Following ICH Q2(R1), compendial, and client-specific guidelines.
Parameter Assessment: Evaluating accuracy, precision, specificity, linearity, and robustness.
Documentation: Comprehensive reporting of validation studies for regulatory compliance.
Transferability: Ensuring methods are ready for seamless transfer to contract providers if needed.

Discover why method validation is essential

Method Validation - Lab Services - QbD Group (1)

Why is method validation important?

Method validation is crucial for:

Regulatory approval: Ensures compliance with international standards and facilitates market access.
Product integrity: Confirms the quality, safety, and efficacy of pharmaceutical products.
Operational efficiency: Reduces risks of non-compliance and enhances analytical reliability.
Risk mitigation: Identifies and addresses potential weaknesses in analytical methods.
Routine testing readiness: Prepares methods for consistent application in quality control.

Discover how we can help you

Regulatory expertise

Adhering to ICH Q2(R1) and relevant guidelines.

Comprehensive validation

Assessing all critical parameters, including accuracy, precision, and robustness.

Tailored protocols

Developing and executing validation protocols specific to your needs.

Validation reports

Providing detailed documentation for regulatory submission.

Transfer readiness

Preparing validated methods for transfer to external laboratories, if required.

Analytical Method Validation - Lab Services - QbD Group (1)

Why partner with QbD Group?

Partnering with QbD Group for method validation provides:

Regulatory knowledge: Extensive experience with global regulatory requirements.
Accurate results: Thorough validation processes to ensure method reliability.
Custom solutions: Tailored protocols to meet your project’s unique needs.
End-to-end support: Comprehensive assistance from validation planning to reporting.

Get in touch

Ready to validate your analytical methods?

Ensure your analytical methods are reliable, compliant, and ready for routine use with QbD Group’s method validation services. Contact us today to discuss your project and learn how we can support your validation needs.

First name*

Last name*

Professional Email*

Company name*

Role*

Department*

Mobile phone number

Country*

Industry *

Question submitted*

Method Validation

What is method validation?

Why is method validation important?

How can we help?

Regulatory expertise

Regulatory expertise

Comprehensive validation

Comprehensive validation

Tailored protocols

Tailored protocols

Validation reports

Validation reports

Transfer readiness

Transfer readiness

Why partner with QbD Group?

Related content

Audit Trail Review in GxP Environments

The Essential CSV & Digitalization FAQ for Life Sciences Companies

Digitalization in the Pharmaceutical Industry: And How to Stay Compliant

Validating a Complex Autoclave Load to Enhance Sterilization Efficiency

Pharmacovigilance and Risk Management in Innovative Therapies: A Challenge in Drug Safety

Extractables & Leachables in Pharma: Navigating Evolving Regulations and Toxicological Challenges

Digital Health - Exploring the landscape and future opportunities

A Complete Guide to Computer System Validation

A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader​

ICH Stability Studies on Pharmaceuticals

EU GMP: How to import your products into the EU?

Guiding a global biotech company through ATMP facility qualification

Restoring manufacturing timelines through expert deviation management

Scalable MSAT validation support for seamless compliance & efficiency

How to keep computerized systems in the operational phase

Regulatory Affairs for Pharma and Biotech

Drug-Device Combination Products and Article 117

Unlocking Strategic Value in Drug Safety for Life Sciences Organizations

How to manage mandatory communication of Toxicological Risks?

GAMP 5 Software Validation Approach for GMP, GCP and GLP regulations

The Basic Concepts of the QbD Methodology

Setting up ATMP Quality Management Systems: Strategies for Compliance and Success

ATMP Supply Chain: Navigating the Challenges and Exploring the Vein-to-Vein Strategy

Achieving laboratory compliance

The One-Vigilance strategic roadmap to corporate excellence

New GMP Facility Qualification: set-up, process and best practices

Annual Product Quality Review in Pharma

Guiding KU Leuven's glioblastoma research to the clinic with precision business planning

21 CFR Part 11 compliance checklist

Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems

Ensuring compliance and quality in Pharmacovigilance

Organic and mutagenic impurities in pharma

The key role of Regulatory Affairs in the pharmaceutical industry: from drug development to commercialization

GAMP categories for computerized systems: what are they and what are they for?

Analytical Method Validation

EUDRALEX Volume 4 Annex 11 Compliance Checklist

From V-model to Agile: how to embrace automation as part of the computerized system validation approach

Innovations in ATMP: state of the industry in 2024

Optimizing pharmacovigilance for a biotechnology leader

Ensuring timely launch: QbD Group's role in establishing a hemophilia drug production line

Revolutionizing pharmacovigilance: a success story of strategic partnership and seamless integration

Ensuring pharmaceutical production quality: cleaning validation for government agency

Patient Support Program (PSP)

Get in touch

A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader