SYNERLAB DÉVELOPPEMENT

Pharmaceutical development centre
GMP site dedicated to solid oral forms

The SYNERLAB DÉVELOPPEMENT site is located in Orléans and is certified as a “pharmaceutical establishment”. Its equipment enables it to offer large capacities (implementation of between a few grams and several kilograms of active ingredients ) for different types of project: development of new chemical entities (oncology, rare diseases, etc.) “life cycle management/OTC products” and “advanced” generic products.

batiment_synerlab_développement

Synerlab Développement

Its core business consists of the pharmaceutical development of innovative drugs.

Thanks to its expertise, SYNERLAB DÉVELOPPEMENT is able to develop effective solutions from the R&D stage through to the manufacturing of statutory batches. The latter include batches for phase I to III clinical trials.

SYNERLAB DÉVELOPPEMENT anticipates optimum industrialisation solutions by working in close cooperation upstream with the Group’s production sites which operate effective manufacturing lines. Responsiveness, flexibility and product and service quality are what drives SYNERLAB DÉVELOPPEMENT on a day-to-day basis. Because every project is unique in the field of pharmaceutical development, SYNERLAB DÉVELOPPEMENT adjusts to the requirements of all its customers. Its aim is to attain customer satisfaction at all times.

The management of development projects:

  • On-going coordination of project management by a dedicated team,
  • Analysis of customer requirements and definition of the target product profile,
  • Communication with the customer via a dedicated project manager,
  • Coordination of a multi-disciplinary team (analytical, galenic, quality assurance),
  • Operational management complying with established deadlines,
  • Link with the experts required to guarantee the success of the project (statutory, pharmacokinetic, etc.).
Galenic development & pharmaceutical operations
  • Pre-formulation
    & formulation

  • Process development,
    supplies of clinical batches

  • Scale-up,
    process validation,
    industrial transfers,
    clinical batches

  • Manufacturing
    of commercial batches
    (niche market)

Analytical development & quality control
  • Formulation support

  • Scale-up support, validation, release of clinical batches

  • Quality control

  • Development & validation of methods

  • Development stability studies with ICH statutory requirements

Packaging
  • Blister packs: PVC/PVDC, Duplex, Triplex, Alu-Alu
  • Pouches
Services
  • Pharmaceutical development project management
  • Raw material supplies (including active ingredients)
  • Galenic development (pre-formulation to industrialisation including development/process optimisation, scale-up, process validation & process transfer)
  • Analytical development (formulation support / development & validation of analysis methods, analytical transfer)
  • ICH stability studies (supportive, clinical, statutory, on-going stabilities)
  • Primary manufacturing & packaging of clinical batches phases I to III
  • Quality control on clinical batches & commercial batches
  • Support for drafting of module 3 of AMM files
  • Dealing with "made to measure" analytical or galenic services
Certifications
  • Pharmaceutical & veterinary establishments
  • Manufacturer of drugs intended for human & veterinary use
  • Manufacturer and importer of experimental drugs for use on humans and veterinary medicines subject to clinical trials

Day-to-day motivation:

Responsiveness, flexibility and product and service quality in a constant concern to guarantee customer satisfaction

Core business:

The pharmaceutical development of innovative drugs

Why choose SYNERLAB DÉVELOPPEMENT?

Because every project is unique in the field of pharmaceutical development, SYNERLAB DÉVELOPPEMENT adapts to the requirements of all its customers.

 

INFORMATION AND CONTACTS

SYNERLAB DÉVELOPPEMENT

1, rue Charles Coulomb
CS 70002
45077 ORLÉANS Cedex 2 France

Tel. +33 (0)2 38 25 02 25
Fax +33 (0)2 38 63 19 93