Analytical services for pharmaceuticals
A reference laboratory to help industrials meet performance and regulatory requirements for pharmaceutical products
FILAB provides analytical services in GMP environment and is the only french laboratory to be ISO 17025 accredited for :
– the analysis of elemental impurities in pharmaceutical products according to USP 233 and EP 2.4.20
– the identification of particles in injectables products
(More information on www.cofrac.fr – accreditation n°1-1793)
FILAB offers pharmaceutical analytical services to pharma industries with a high level of skill and a cutting-edge analytical fleet to provide services fulfilling their criteria in terms of compliance to standards relevant to all kinds of galenic pharmaceutical formulations :
Finished products
Active Pharmaceutical Ingredients (API)
Excipients
Packaging
OTC
Powders
Our services
DEVELOP & VALIDATE - analytical methods
- Analytical development
- ICH Q2 Validation
- Analytical transfer
- Training
CONTROL - the quality of a product
- Chemical analysis
- Quantification of elemental impurities (USP 233 guideline)
- Quantification of Residual solvents (USP 467 guideline)
- Powder analysis
SOLVE - a problem
- Characterization of unknown impurities
- Particles contamination
- Change in appearance
- Product degradation
ASSESS - the stability of a product
- Extractables and Leachables
- Stability studies
- Degradation products
A laboratory dedicated to
FILAB laboratory is the only French laboratory to be ISO 17025 accredited for the analysis of elemental impurities in pharmaceutical products and for the analysis of pharmaceutical formulations in accordance with GMPs.
We have all the equipment and techniques needed for pharmaceutical testing :
Chemical analysis : UPLC-MS/MS, UPLC-QTOF, LC-UV, GC-MS (HS, TDU…), ICP-AES, ICP-MS, ICP-MS/MS, IC…
Materials and powders characterization : SEM-EDX, XRD, DSC, BET, Granulometry, SEC, µ-FTIR, AFM…
French Laboratory
based in DIJON (21)
Pharmaceutical tests, but also...
- Bibliography studies
- Training for analytical validation (ICH Q2)
- Laboratory Lean Management
- Training for analytical technics (MEB, ICP, GC, DRX, DSC,...)
- On-site process audit
- Substitution of a CMR product
Ask for a quotation
FILAB S.A.S
Parc Mazen Sully 13, rue Pauline Kergomard
BP 37460 21074 DIJON CEDEX – FRANCE
Tél. +33 (0)3 80 52 32 05