Analytical development
The development of new methods of analysis, their validation, the elaboration of registration dossiers (ASMF, IND, AMM, NDA)
Analytical development and regulatory support
SYNTH-INNOVE Laboratories quality department staff has an extensive expertise in the development of new analytical methods and a good experience in the constitution of registration files.
A large array of state-of-the-art material
Purity testing by HPLC with UV-VIS, refractometric or fluorimetric detection
HPLC or GC assay methods
Titration assay methods
GC methods for the quantitation of residual solvents
Study of impurity profile by HPLC-MS or GC-MS
Structure elucidation of degradation products by Mass spectrometry
Impurities traces quantitation by HPLC with chemical derivatization
Separation of enantiomers by HPLC (Chiral chromatography)
Analysis of amino-acids by HPLC with fluorimetric detection
Molecular weight distribution of polymers by SEC
Validation of analytical methods
APIs Polymorphism studies
Stability studies according ICH guidelines
Regulatory Affairs in Europe and in USA
The development and validation reports edited by SYNTH-INNOVE meet the ICH guidelines recommendations and satisfies the requirement for a DMF registration. SYNTH-INNOVE Laboratories has more than 12 years experience in the constitution of registration files and an excellent expertise in meeting the requirements for European Registration. All APIs Regulatory Documentations submitted to the authorities in Europe or in France by SYNTH-INNOVE laboratories were successfully registrated.