Our teams design, develop, and validate the essential analytical methods for controlling the quality and regulatory compliance of your products.
Integrated analytical expertise is a cornerstone of our CDMO support, whether for new projects, technology transfers, or scale-up.
We cover all analytical needs for early-stage development:
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Analytical method development and validation
In accordance with ICH Q2: identification, assay, purity, dissolution, viscosity
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Analytical method transfer
Intra- or inter-site transfer, equipment adaptation, method verification
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Storage and stability studies
In accordance with ICH guidelines: climatic zones I to IV (?), long-term and accelerated conditions, full protocol and monitoring
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Specific risk assessments
Extractables & Leachables (E&L), elemental impurities (ICH Q3D), Nitrosamines and genotoxic impurities - Photostability (ICH Q1B)
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Cleaning process validation
Development of residue assay methods, definition of critical thresholds, initial protocol validation
Analytical work is coordinated with all project services to ensure an integrated and coherent approach.
This integrated approach helps to improve fluidity, traceability, and compliance.
A laboratory integrated within our development site
Mastery of international standards: (to be specified)
Expert teams, in direct liaison with formulation, regulatory affairs, and clinical production development
Ability to build your CMC documentation and secure your initial submissions
Yes. Our facilities are suitable for managing stability programs in all ICH climatic zones, with long-term, intermediate, and accelerated conditions.
Our services comply with ICH Q2(R1) and GMP standards and the requirements of multiple health authorities (EMA, FDA, etc.).
Analytical development is the creation, validation, and optimization of methods used to analyze a product (whether formulated or not). It is forward-looking and often conducted upstream, in order to define how product control will be carried out.
It encompasses all the work required to develop, validate, and apply reliable quality control methods, from the pre-clinical or clinical phases.
Yes. We carry out comprehensive analytical and documentary assessments: nitrosamines and genotoxic impurities, elemental impurities (ICH Q3D), extractables and leachables (E&L), and photostability (ICH Q1B). This work is carried out in direct relation to the process and equipment and in accordance with EMA and FDA requirements.
