Analytical Method Development, Validation & Transfer
Analytical procedures should be designed around the purpose of the method, the properties of the analyte and matrix, and the stage of development.
Teleios supports development, optimization, validation, verification, and transfer of analytical procedures for pharmaceutical development and testing.
What We Can Support
- Method development
- Method optimization
- Assay and impurity methods
- Stability indicating procedures
- Method validation
- Method verification
- Method transfer
- Troubleshooting and investigation of existing procedures
Typical Analytical Questions
- Is the method selective for the analyte and relevant impurities?
- Can the method reliably measure the required concentration range?
- Is the procedure robust to reasonable operational variation?
- Is the method suitable for its intended use?
- Can the procedure be transferred successfully between laboratories?
Analytical Approach
Study design begins with the analytical question and the intended use of the data. Chromatographic and detection conditions are selected for the analyte and matrix, then challenged for selectivity, range, and robustness before validation or transfer activities.
Regulatory & Compendial Framework
Depending on the program, material, and intended use, studies may consider:
- ICH Q14 — Analytical Procedure Development
- ICH Q2(R2) — Validation of Analytical Procedures
- Applicable USP general chapters and product specific monographs
- Relevant FDA and regional regulatory expectations
Not every listed framework applies to every study. Applicable expectations depend on product type, development stage, route of administration, material, intended use, and jurisdiction.