Development services

A full range of activities from project to product

Development Services

A full range of activities from project to product

22 start-ups supported

more than 8 therapeutic areas

Small molecules, biologics, peptides, cellular therapy

22 start-ups supported

more than 8 therapeutic areas

Small molecules, biologics, peptides, cellular therapy

How can we help?

CMC

CMC

  • Support in the identification of critical partners (CDMO) for:
    • drug substance synthesis
    • formulation development
    • analytical development and validation
    • drug product manufacturing
  • Guidance in the setting of specifications appropriate per dosage form, intended use and in relation to the phase of development
  • Insurance of quality and consistency at each step of the manufacturing process throughout the clinical development
  • Writing of the CMC sections of the IMPD / CTD required for regulatory submission

PRECLINICAL DEVELOPMENT

DéVELOPPEMENT PRéCLINIQUE

  • Support in the preparation of the non-clinical development plan to be compliant with the regulatory pre-requisites
  • Advice on the safety pharmacology, pharmacokinetic and toxicological studies in light of the FIH trial study design (route of administration, frequency of administration, duration of the clinical trial) and throughout the clinical development
  • Writing of the non-clinical sections of IMPD / IB / CTD required for CTA / MAA

FIRST IN HUMAN STUDY

PREMIèRE ADMINISTRATION CHEZ l’HOMME

  • Advice on clinical trial dossier requirements and use of CTIS database for clinical trial applications
  • Support in the writing/review of the key regulatory documents required for the clinical trial application (CTA / IND dossier)
  • Help with the CRO selection

REGULATORY

Règlementaire

  • Advice on the regulatory requirements from preclinical stage until MAA
  • Elaboration of a regulatory strategy and roadmap taking into account stage of development, planning and costs constraints
  • Support in the development and maintenance of the TPP
  • Writing/review of:
    • the briefing document for scientific advice
    • ODD request
    • PIP
    • RMP
    • CTD (Module 1 to Module 5)
    • MAA
  • Submission to Competent Authorities/EMA of request for scientific advice, ODD, PIP.

PROJECT
MANAGEMENT

GESTION DE PROJET

  • Elaboration of a roadmap and budget to achieve the project milestones from late-stage research to market
  • Support in the planning and tracking of project timings & cost
  • Identification of suitable partners (CDMO, CRO) and creation of a working group able to anticipate and react
  • Management and follow-up of the Quality, Pre-clinical and Clinical activities with the different selected partners

INVESTOR PITCH FOR FUNDRAISING

PITCH INVESTISSEUR

  • Customization of the pitch: highligthing the innovation and scientific/medical needs
  • Analysis of the competitive landscape
  • Help in the development plan and corresponding costs – key milestone to reach for value creation
  • Support in the preparation of the package required for investors meeting

We guide you through all steps,

from your lead candidate

to registration

Nous vous guidons à toutes les étapes depuis la sélection de votre candidat jusqu’à son enregistrement.