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About us

DIVERCHIM is a Small Molecule Drug Substance CDMO which focuses on developing and manufacturing high added-value ingredients: 

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  • Drug candidates APIs

  • APIs for Orphan Drugs and Rare Diseases

  • Radiopharmaceutical Precursors

  • Niche specialty chemicals​​

  • Emergency medications​

More than 20 years serving the development of New Chemical Entities​,

from a CRO to a CDMO

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Memberships

Our values

Memberships

DIVERCHIM is highly committed in running its business with high level of ethical considerations and developing manufacturing processes that are environmentally responsible.

Safety

Gender Equality

45% 
55% 

Certification in progress

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Yasmine

Bencheikh

  • LinkedIn

HSE Manager

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Claire

Brayer

  • LinkedIn

Office Manager

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Bruno

Dudot

  • LinkedIn

Head of Large Scale Production

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Benoît 

Folléas

  • LinkedIn

CSO, Head of Project

Management

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Sylvie

Girardet

  • LinkedIn

QA and Regulatory

Affairs Director

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Fabien

Lajus

  • LinkedIn

Head of QC Lab. And Analytical Development

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Jessica

Le Manac'h

  • LinkedIn

Head of HR and Accounting

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François

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Macarez

  • LinkedIn

CEO

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Cédric 

Ngoulou

  • LinkedIn

Head of Purchasing

Solutions

Comprehensive offering, from Preclinical stage to Commercial, dedicated to the

development and manufacturing of: 

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  • Small molecule APIs (including RSM and advanced intermediates)

  • Radiopharmaceutical precursors

  • GMP excipients and Linkers

  • Polymers, Nano-lipids and Hydrogels

Services
Development phase

Additional services include:

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  • Lyophilization and Solid aliquotation of Radiopharmaceutical precursors

  • Reference standards

  • Standalone analytics

•  Team of 5 lead by QA Director, Org. chemist by training with 20-year experience in QA

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•  ICHQ7 based quality system

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•  GMP certification of the site since 2015

•  Last audit: July-22

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•  Mock inspection Oct.- 2021(site registered by FDA since 2021)

•  PAI expected Q4 2024 – Q1 2025

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•  DMF files submitted & accepted (EU + Switzerland + USA): 5

•  DMF files to be submitted: 10

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•Project management Director, member of Comex team

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•Nomination of a dedicated PM at the start-up of each project

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•Project team includes experts of all services to ensure a smooth execution to comply with customer’s request

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•Management of activities (Route  scouting, Developments, Validation,  Stability studies,  Production) handled by a PM

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•The PM  is the privileged contact of the customer during the whole product life cycle

State-of-the-art 3000 m² facility built in 2013 including:

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  • Our facility is strategically located just 20 kilometers north of Paris, near the Roissy-Charles de Gaulle airport

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  • This prime location provides us with exceptional connectivity, allowing for efficient logistics and accessibility to key international hubs

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Capabilities
Special Features
Lyophilization (Dispensing and Freeze-Drying capabilities)

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“Ultra-clean” vials preparation in dedicated cGMP area

 

Development studies:

•Identification of CPP/KPP/nCPP

•Determination of PAR/NOR

•Ensure process robustness and GMP compliance

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Current capacities:

- 400 2R Vials / run

- 180 10R vials / run

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Additional capacities (investment in progress – operational T2/T3 2024):

- 1100 2R Vials / run

- 310 10R vials / run

(Dispensing and Freeze-Drying capabilities)

“Ultra-clean” vials preparation in dedicated cGMP area

 

Development studies:

  • Identification of CPP/KPP/nCPP

  • Determination of PAR/NOR

  • Ensure process robustness and GMP compliance

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Current capacities (2 equipment):

  • 400 / 1100 2R Vials / run

  • 180 / 310 10R vials / run

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News

Let's meet!

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See it on LinkedIn

Contact
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