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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.

Additional know-how

Research & Development

Production

Quality Control

Analytical Development