Validation & Qualification Method Validation Services

Prove your analytical methods deliver accurate, reliable results through comprehensive validation that demonstrates fitness for purpose while optimizing laboratory efficiency.

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Ensure confidence in every measurement

Analytical methods form the foundation of quality decisions—from raw material acceptance through product release. Invalid methods produce invalid results, leading to incorrect decisions that compromise quality and compliance. Yet method validation challenges even experienced laboratories with complex statistics, evolving guidance, and the need to balance thoroughness with practicality.

Effective method validation goes beyond checking ICH boxes. It requires understanding your specific analytical needs, designing studies that reflect actual use conditions, and generating data that proves reliability. From compendial verification to novel method development, success depends on scientific rigor combined with regulatory insight.

Our method validation experts include analytical chemists, statisticians, and former FDA laboratory reviewers. We understand both the science and the regulations, helping you develop validation strategies that satisfy inspectors while serving your operational needs.



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Our method validation services include:

  • Validation strategy and protocol development
  • ICH Q2(R1) parameter assessment
  • Specificity and selectivity studies
  • Linearity and range determination
  • Accuracy and precision evaluation
  • Detection and quantitation limits
  • Robustness testing design
  • Stability indicating method validation
  • Compendial method verification
  • Method transfer protocols
  • Statistical analysis and interpretation
  • Validation report preparation
  • Regulatory defense strategies

Method types we validate include but are not limited to:

  • Assay and purity methods
  • Impurity and degradation methods
  • Dissolution testing
  • Content uniformity
  • Residual solvent analysis
  • Cleaning verification methods
  • Bioanalytical methods
  • Microbiological methods
  • Raw material identification

Click to expand Our approach to analytical method validation

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We structure our support around three pillars—Strategy & Design, Execution & Analysis, and Transfer & Defense—so your methods are robust, usable, and inspection-ready.

  • Strategy & Design

    • Define validation scope and acceptance criteria (routine, stability-indicating, or compendial).

    • Map parameters per ICH Q2(R1): specificity, linearity, accuracy, precision, robustness, LOD/LOQ.

    • Develop statistically sound protocols covering samples, replicates, and robustness factors.

    • Plan stability-indicating and forced-degradation studies to confirm long-term reliability.

    • Prepare method transfer plans and acceptance criteria for CRO or internal site transfers.

  • Execution, Data Analysis & Interpretation

    • Evaluate specificity/selectivity to ensure the method distinguishes analyte from interference.

    • Demonstrate linearity, range, and proportional response across concentrations.

    • Assess accuracy and precision (repeatability, intermediate precision, recovery).

    • Determine sensitivity thresholds (LOD/LOQ) through statistical or S/N methods.

    • Conduct robustness testing under controlled variations in key parameters.

    • Verify stability and degradation under stress or extended storage.

    • Perform compendial verification to confirm equivalency to USP/EP/JP procedures.

    • Apply statistical tools to evaluate results, trends, and data integrity.

    • Compile comprehensive validation reports with clear narratives and traceability.

     

  • Transfer, Defense & Support

    • Execute method transfers with replicative data and acceptance criteria.

    • Support regulatory defense and respond to FDA or global health authority inquiries.

    • Define and manage revalidation triggers (e.g., matrix changes, new instruments, software).

    • Integrate validated methods into SOPs, train analysts, and align with your QMS. 

  • Method Types & Use Cases

    • Assay / Purity / Potency analyses

    • Impurity / Degradation / Forced-degradation methods

    • Dissolution / Release / Content Uniformity

    • Residual solvents / Volatiles

    • Cleaning validation methods

    • Bioanalytical / PK / Concentration methods

    • Microbiological / Microbial limit / Sterility

    • Raw material identification / Characterization

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Why teams work with us for validation projects

  • Scientific expertise: Deep analytical and statistical knowledge
  • Regulatory insight: Know what FDA expects in submissions
  • Practical approach: Validation that supports routine use
  • Efficiency focus: Streamlined protocols without compromising quality
  • Global perspective: Meet FDA, ICH, and international requirements

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Why work with The FDA Group?

 
  • Exclusive life science focus and expertise
  • Dedicated account management team
  • Right resource, first time (95% success)
  • 97% client satisfaction
  • Total Quality Guarantee

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Our Proven Process

Introductory Conversation

  • About Us
  • About You
  • Scope Of Work

Resources Definition

  • Background And Expertise
  • Location Of Resource
  • Rate Rightsizing

Proprietary Resource Selection Process

  • In-House Subject Matter Experts
  • Recruiting Team External Search
  • Resource Identification

Resource Presentation

  • CV And Rate
  • Perfect Match Summary
  • Interview Call Coordination

Agreement Processing

  • MSA And Addendums
  • Supplier Qualification
  • Kickoff Coordination

Account Management

  • Project Management Of Resource
  • Satisfaction Management of Client
  • Total Quality Guarantee

Contact us and get the conversation started.

Our resources can be utilized to meet the wide range of remediation requirements throughout the life sciences, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.

Please contact us to learn more about fulfilling specific validation needs. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.