The SYNERLAB Group has been assisting dozens of laboratories with their pharmaceutical development problems for over 20 years.
AN EXPERT IN ITS FIELD
The SYNERLAB Group is an ideal partner for the initial stages in the formulation of batches for clinical trials, from phases I to III through to manufacturing on an industrial scale.
The diversity of our technical platforms and the professionalism of our teams of experts (project, analytical and quality departments) enables us to manage your development programmes and provide real added value for the completion of your projects.
As an expert in contract services, the SYNERLAB Group meets all your requirements through its international, multi-disciplinary teams, made up of Doctors in Chemistry, pharmacists, engineers and experienced technicians. These experts are qualified to deal with scientific, technical, industrial and statutory issues so that CMC source files can be drafted for your IND/IMPD/AMM files.
The SYNERLAB Group also deals with development, optimisation and validation issues according to international statutory requirements, and handles the transferral of new analytical methods for all kinds of drugs.
Thanks to their strong industrial vision, our employees have recognized ability to manage analytical transfers, whilst anticipating the specific features of the different production sites.
A COMPLETE RANGE OF ANALYTICAL SERVICES
- Analyses to support the formulation and reliability of manufacturing processes,
- Development of analysis methods for the main active ingredients and finished products (e.g. doses, purity, dissolution, etc.),
- Validation of analysis methods, including reliability studies,
- Transfers of analysis methods (in & out),
- Optimisation and statutory conformity of methods,
- Analytical trouble-shooting,
- Definition of specifications/control monographs for finished products adapted to each development stage,
- Development and validation of the cleaning verification method,
- Forced degradation and pre-stability studies for selections of formulae/packaging, compatibility studies on main active ingredients and excipients,
- Stability studies according to ICH,
- Analyses and release of clinical batches,
- Support for the drafting of module 3 of AMM files and clinical investigation files (IND/IMPD).
Our pharmaceutical technology and physical chemistry laboratories focus specifically on analytical services with a wide range of equipment:
- Liquid chromatography systems (HPLC, UPLC, UV and PDA detectors),
- Dissolution devices: USP1 and USP2 types, off/on line, automata, near infra-red,
- UV and IR spectrophotometers
- QDA mass detectors, laser grading, etc.