Development, Production, Quality & Regulatory services

We offer:

Developement

Process and analytical development

  • Chemical and technological development
  • Analytical method development
Production

Pilot production and industrial scale production

  • Preclinical and clinical batches production
  • Advanced Intermediates production
Quality

Regulatory dossier

in collaboration
with the Servier network
  • CMC File Preparation
  • Investigational Medicinal Product Dossier (IMPD)
  • DMF file support

Expertise fields

Process

  • Organic Chemistry
  • Hydrogenation
  • Hazard evaluation of processes (Calorimetric studies, C80, Labmax, DSC…)
  • Crystallization
  • Preparative Chromatography
  • HAPIs handling (from a few grams to several kg)

Analysis

  • Development of analytical methods
(LC, GC, UHPLC….)
  • Identification techniques
(RMN, LC/MS coupling…)
  • Ultra-trace Assay
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Manufacturing

  • Synthesis
  • Isolation technology
  • Drying/solid treatment
  • Packaging

Analytical

  • Chromatographic methods
    (LC, GC, HS-GC, UHPLC…)
  • Potentiometric Assay
  • IR and UV Spectrophotometry
  • LC/MS coupling
  • Electrophoresis
  • RMN 1H, 13C, 31P

Technologies
& equipment

Reactors

Capacity: from 8 L to 10 000 L
(Inox, Hastelloy and Enamel types)
Temperature: from -40°C to +140°C
Pressure: atmospheric

Hydrogenators

Capacity: from 8 L to 4 000 L
(Inox and Uranus types)
Temperature: +25°C to +270°C
Pressure: from 1 bar to 250 bars
(hydrogenation)

Isolation: Filters or Centrifuges
Drying/Solid Treatment Tray dryers, Tumble dryers,
Grinders, Micronizers

Chemical reactions

  • Acylchlorides
  • Acylation
  • Alkylation with alkylating agents
  • Amination and amidation
  • Aromatic substitution
  • Catalytic hydrogenation
  • Chiral center inversion
  • Condensation reaction
  • Deacylation and dealkylation
  • Eliminination reaction
  • Esterification
  • Friedel & Crafts Alkylation/Acylation
  • Grignard reaction (low temperature -60°C)
  • Halogenation
  • Heterocycle formation
  • Hydrolysis / Alcoholysis

For our Chemical services, contact us

Contact us