Emery Pharma is a GLP/GMP-compliant CRO providing analytical method development, validation, and transfer services. We recognize that accurate, reproducible analytical methods are the backbone of a successful pharmaceutical program.
From early-stage R&D feasibility to formal cGMP batch release, our Method Development, Transfer, and Validation services ensure your therapeutic candidates meet the most stringent standards of safety, identity, and purity. Leveraging state-of-the-art instrumentation—including High-Resolution Mass Spectrometry (HRMS), LC-MS/MS, and NMR—our expert team designs custom assays tailored to the unique physicochemical properties of small molecules, biologics, oligonucleotides, and peptides. Whether you are navigating the complexities of IND-enabling studies or preparing for commercial launch, we deliver scientifically rigorous, audit-ready data that is compliant with ICH Q2(R2) and FDA guidelines.
We routinely support CMC leads, QC/QA managers, and virtual biotech program teams who need GLP/GMP-ready methods for release, stability, and regulatory submissions.
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Target Industry
Pharmaceuticals, Biotechnology
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Applicable Standards
USP〈1224〉 Transfer of Analytical Procedures; ICH Q2(R2) Analytical Method Validation
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Target Product / Molecule Type
Small molecules, Biologics, Oligonucleotides, Peptides
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Instrumentation & Analytical Platforms
LC-MS/MS, UPLC-UV, GMP qNMR, HRMS, GC-MS, UPLC-CAD, UPLC-RI, UPLC-FLD, Ligand Binding Assay (LBA)
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Turnaround Time
Depends on the scope of the method
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Sample Requirements
Depends on the scope of the method
Method Development, Transfer, and Validation Services
Moving an analytical procedure from a development environment to a quality control laboratory is a critical step that demands precision to prevent costly delays. Our services bridge this gap by prioritizing data integrity and regulatory compliance. We adopt a lifecycle-based approach to validation and transfer, ensuring that your methods remain robust and fit-for-purpose regardless of the testing site. Whether you require a formal Method Transfer per USP 〈1224〉 to harmonize inter-lab performance or a full GLP Validation to support a regulatory filing, Emery Pharma provides the technical expertise and comprehensive documentation necessary to streamline your path to market.
Method Development
Description
Emery Pharma develops fit-for-purpose analytical methods tailored to R&D and regulated applications. These methods support product characterization, release testing, formulation development, and stability-indicating assay needs.
Methodology
Method development is performed using LCMS-MS, H-NMR, 13C-NMR, GMP qNMR, GC-MS, UPLC-UV, UPLC-CAD, UPLC-RI, UPLC-FLD, and LBA instrumentation. Our team optimizes chromatographic conditions, detection strategies, and system parameters to deliver robust methods for small molecules, biologics, oligonucleotide, and peptides. Development strategies support subsequent transfer and validation under ICH and compendial frameworks.
Deliverables
- Custom method development plan
- Optimized analytical procedure with supporting data
- Preliminary robustness and performance assessments
- Recommendations for validation and lifecycle progression
Method Transfer
Description
This service ensures that a validated analytical method (compendial, regulated, or R&D) is successfully transferred and implemented in a recipient laboratory, guaranteeing consistent performance, knowledge, and data integrity across sites.
Methodology
We follow the documented, risk-based process defined in USP 〈1224〉 Transfer of Analytical Procedures, designing a tailored transfer protocol (master plan), then executing comparative testing or co-validation using instruments such as LC-MS/MS, UPLC, NMR, and more.
Deliverables
• Method transfer protocol
• Summary of acceptance criteria and results
• Investigation of any deviations and corrective actions
• Transfer report and knowledge-transfer documentation
Regulatory Method Validation
Description
We rigorously validate analytical methods to meet regulatory expectations using ICH Q2(R2) guidelines, ensuring your assays are robust, accurate, precise, and ready for submission in IND/clinical or commercial filings.
Methodology
Our validation studies are aligned with ICH Q2(R2) requirements, assessing key performance parameters such as specificity, accuracy, precision, linearity, range, detection & quantitation limits, and robustness. We apply a life-cycle approach to validated methods, also considering combined evaluation of accuracy and precision and leveraging modern instrumentation (LC-MS/MS, UPLC, NMR, HRMS, etc.).
Deliverables
• Validation protocol (predefined acceptance criteria)
• Summary report of validation data (specificity, linearity, LOD/LOQ, precision, etc.)
• System suitability criteria
• Combined vs separate accuracy/precision evaluation (if applicable)
Request Your Method Development & Validation Services
Our Scientists
Dr. Prajita Pandey, Ph.D. is an accomplished analytical chemist and Associate Director of the Chemistry Department at Emery Pharma, where she leads biologics characterization and protein analysis initiatives. She specializes in developing and validating analytical methods for complex biomolecules such as monoclonal antibodies, ADCs, peptides, and proteins using advanced LC-MS and LC-HRMS technologies.
Why Choose Emery Pharma for Method Development, Transfer & Validation
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GLP/GMP Compliance
Our validation and transfer operations are executed under strict GLP/GMP frameworks, ensuring your data is defensible for regulatory submissions and audits. -
Regulatory Expertise
We are well versed in regulatory standards, from USP 〈1224〉 for method transfer to ICH Q2(R2) for validation. This expertise helps minimize risk and streamline audit readiness. -
Breadth of Instrumentation and Methodologies
Emery Pharma maintains a full suite of analytical platforms, including LC-MS/MS, UPLC, NMR, HRMS, GC-MS, and LBA, enabling method transfer and validation across small molecules, peptides, oligonucleotides, and biologics. -
Rapid Turnaround Times
Per USP 〈1224〉, we accelerate method transfer, aim for inter-lab harmonization, and onboard our client's methods faster. -
Lifecycle-Based Validation Philosophy
Leveraging ICH Q2(R2) and the analytical lifecycle concept, we design validation strategies that balance rigor and efficiency, including combined accuracy/precision approaches, to optimize resource use.
Case Study: Solving Equipment Mismatch in Method Transfer The Challenge:
A client needed to transfer an impurity method to a site with different Mass Spec capabilities (QQQ vs. HRMS). The Solution: Emery Pharma executed a bridging study demonstrating >99% correlation (R² > 0.9) between platforms. The Result: Successful regulatory alignment and seamless transfer without requiring new capital expenditure.
projects delivered on time
average lead time for study initiation
response time to new requests
Frequently Asked Method Development & Validation Questions
What is the typical workflow from an R&D method to a fully validated method?
The workflow generally progresses through four stages:
- Method Development, where the technique and parameters are established;
- Method Qualification, where basic performance (e.g., accuracy, precision) is demonstrated to support early studies;
- Method Optimization based on stability or matrix findings; and
- Full GLP/GMP Validation using a formal, QA-approved protocol to meet regulatory requirements (e.g., ICH Q2(R2)).