Develop, validate, or verify a method
Build or qualify a procedure around its intended use, matrix, evidence requirements, and future laboratory workflow.
Choose the correct method lifecycle path before work begins
The correct service depends on what already exists and what the resulting data must support. Triclinic Labs helps pharmaceutical teams develop a new analytical procedure, demonstrate that a procedure is fit for its intended use, verify an established procedure in a specific laboratory and matrix, transfer a method between laboratories, or execute a release-ready method under current good manufacturing practice (cGMP).
Content scientifically reviewed by Andy Gilkison, Ph.D., Senior Director, Method Development at Triclinic Labs · Updated 9/1/2026
Start with the decision the method must support
| Current situation | Recommended path | Primary outcome |
|---|---|---|
| No suitable analytical procedure exists | Method development | A practical procedure designed for the material, matrix, and intended use |
| A noncompendial procedure must demonstrate fitness for use | Method validation | Documented performance against scientifically justified characteristics and acceptance criteria |
| A compendial procedure must work in a specific laboratory or matrix | Method verification | Evidence that suitable performance can be achieved under the proposed conditions |
| An existing method must move to another laboratory, site, instrument, or quality system | Method transfer | Documented receiving-laboratory readiness and comparable execution |
| The method, specification, controls, and documentation are release-ready | cGMP release testing | Controlled testing and reporting to support the authorized batch-disposition process |
Transfer an established method
Assess the method package, select the transfer model, control laboratory differences, and document receiving-site performance.
Execute a release-ready method
Apply a validated, verified, or transferred method under controlled cGMP procedures for release, stability, or specification testing.
What to provide for an initial method assessment
Share the current procedure or draft, intended use, material and matrix, specification or decision limit, prior performance data, reference standards, known interferences, instrument constraints, quality status, and required timeline. Triclinic can then identify the appropriate lifecycle stage and any gaps that should be resolved before a protocol is written.
Common Questions
Common QuestionsWhat is the difference between method development, validation, verification, and transfer?
Development creates or optimizes the procedure. Validation demonstrates that a noncompendial procedure is fit for its intended use. Verification confirms suitable performance of a compendial procedure in a specific laboratory and matrix. Transfer demonstrates that a receiving laboratory can execute an existing procedure under defined conditions.
Does every analytical method require full validation?
No. The required evidence depends on the procedure, intended use, regulatory status, sample matrix, risk, and existing performance package. A compendial procedure may require verification, while a noncompendial release method generally requires validation.
When is a method ready for cGMP release testing?
A method is release-ready when its status, specification, system suitability, reference standards, sample controls, documentation, review process, and validation, verification, or transfer evidence support the intended quality decision.
Can Triclinic support solid-state and solution-phase analytical methods?
Yes. Projects may use chromatography, spectroscopy, mass spectrometry, X-ray powder diffraction, thermal analysis, particle-size analysis, microscopy, elemental analysis, nuclear magnetic resonance, or an orthogonal combination selected for the material and decision. Availability for cGMP execution depends on the qualified status of the technique, instrument, method, and laboratory workflow.
What information helps Triclinic scope the work?
Provide the procedure or draft, intended use, material identity, sample matrix, acceptance criteria, prior data, reference standards, known interferences, instrument constraints, sample handling requirements, quality status, and timeline.
Discuss the method decision before writing the protocol
Tell Triclinic what material, method, matrix, acceptance criteria, regulatory status, and timeline are driving the work.
