Analytical Development Laboratory
Our mission is to develop and validate reliable methods
Overview
Our team of analytical experts offer extensive services that include the following:
- Development and validation of analytical methods for drug substances, excipients, drug products, raw materials and cleaning methods: Quality by Design (QbD) and total error approach validation
- Development and validation of diffusion profiles adapted to formulation
- Development and lifecycle update of analytical methods according to major guidelines and pharmacopeias (ICH, EMA, FDA, USP, EP)
Services
As Analytical Development Laboratory, our mission is to develop and validate reliable methods for their intended purpose supporting by documentation of analytical protocols and reports.
This is conducted in compliance with the Notes for Guidance Validation of Analytical Procedures, Definitions and Terminology and Validation of Analytical Procedures, Methodology by the ICH (Q2A, Q2B) and FDA guidelines, along with a solid statistical approach based on total error approach.
After full validation, a method may require a transfer. Our team has experience in supporting such method transfer: involving comparative testing, co-validation between two sites (lab-to-lab) and sometimes complete or partial revalidation (transfer plan, protocol, report).
Stability studies or forced degradation (ICH) linked to drug substances, excipients, drug products and finished products could be handled by the know-how of our expert team.