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Analytical Method Transfer, Maintenance & Validation

Life Sciences / Central Laboratory Services / Analytical Methods / Analytical Method Transfer, Maintenance & Validation

Comprehensive Analytical Method Management

Leverage our comprehensive analytical method transfer, method validation, and maintenance services to support your drug products and medical devices. Analytical testing is a foundational activity throughout every phase of pharmaceutical and medical device development and commercialization. Our team provides reliable, responsive support for managing analytical methods throughout your product’s lifecycle. We offer guidance and services for analytical testing design, development, optimization, qualification, validation, transfer, and maintenance.

By partnering with our organization, your program relieves internal capacity, allows experts to refocus on alternative activities, transfers work when existing lab operations close, and gathers data supporting method reproducibility across our nationwide network of laboratories.

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Analytical Method Services

Method Development
Method Optimization
Method Transfer
Method Maintenance
Method Development

We create robust, phase-appropriate methods to address well-defined parameters and prepare for future pharmaceutical product development activities. Our experts offer techniques and validation for solubility, dissolution, stability, and solid form definition. We’re experienced in evaluating and, if necessary, redeveloping existing methods to meet specific endpoints.

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Method Optimization
If your method requires improvement to meet your evolving needs, our team offers services to optimize it for the current or upcoming phases. Optimizing analytical methods often aims to prepare routine assays with shorter run times while retaining equivalent results. We also help adjust methods as products lines or applications evolve. When partnering with us, your support is powered by multiple GMP laboratories in our network, which helps test methods at multiple site locations as evidence for reproducibility.
Method Transfer

When transferring methods into our lab, we follow specific method transfer protocol and United States Pharmacopoeia (USP) General Chapter <1224> guidance. Our team supports strategy selection, protocol drafting, transfer activities, and final summary reporting. We collaborate with you to select a choice strategy based on the method complexity, the method type (identification, qualitative limit test, quantitative assay, performance indicator, etc.), and the analytical technique (chromatography, spectroscopy, wet chemistry, etc.). With multiple GMP laboratories within our nationwide network, we are also able to perform analytical method validation internally.

Method Maintenance

We handle analytical method maintenance to ensure your documentation and methodology is appropriate for current regulations and applications. Our team adapts methods for product changes or applies existing methods to new products. In situations where regulators are applying pressure or when our experience reveals underlying trends, we offer guidance to resolve concerns and support to meet key objectives.

Secure Data Accessibility

Analytical methods, including both the Client Laboratory Methods (CLM) and Laboratory Methods (LM), are available for your access and review in PacePort. PacePort is our secure client data access portal and web-based data delivery system where you have access to methods, specifications, stability protocols, pull schedules, stability reports, final reports, sample receipt data, instrument raw data, and additional information at any time, from any location.

The copies are offered in high-resolution and in color, giving your team easy and clear viewing for review. Scanned images are of sufficient quality that they are often used during quality and regulatory (US FDA) audits. The information available via PacePort is thorough and complete, such that most, if not all, aspects of a data audit are available so your audit could be conducted remotely, guided by our Quality Assurance personnel.

Integrated Laboratory Services  

When your team needs additional support, our scientists & professional services are ready. Our state-of-the-art facilities and highly trained experts add power to your project.

Additional Resources

Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.
Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.
Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.
Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.