Médicaments chimiques, protéines recombinantes, thérapies ciblées, statut orphelin, medical device…
Piloter les projets dans la durée, anticiper les difficultés, évaluer les résultats, constituer des partenariats académiques et industriels : pour chaque mission qui nous est confiée, nous mobilisons les meilleurs compétences internes et externes en étroite relation avec vos collaborateurs.
À chaque projet, nous constituons une équipe pluridisciplinaire qui intervient en support sur certaines étapes spécifiques du développement ou qui le prend en charge dans sa globalité.
ODD
QPPV
PIL
RMP
CTD
IMPD
MA
IMPD
eCTD
ODD
QPPV
CTD
PIP
CTD
PSUR
PIL
RMP
STRATÉGIE GLOBALE DE DÉVELOPPEMENT
Définition d’un profil cible de produit
Conception d’un plan de développement (Road-Map)
Analyse de risque / QbD
Design des protocoles d’étude à mettre en œuvre
Stratégie d’enregistrement
Études de casManagement de projet et coordination des études à mettre en œuvre
Sélection des partenaires CMO / CRO sur appel d’offres
Audit / coordination des partenaires
Supervision des étapes clefs des essais cliniques
Suivi budget / planning / Reporting client
SUPPORT RÉGLEMENTAIRE
Brochure investigateur et dossier pour essais clinique (IMPD/IND)
Désignation pour médicament orphelin (ODD)
Plan d’Investigation Pédiatrique (PIP)
Dossier d’AMM / NDA / BLA
Procédure PRIME / Fast Track
Interaction avec les autorités de santé (eu/us/export)
Préparation de la documentation pour avis scientifique
Préparation de la documentation pour le dossier de pré-soumission
Participation aux réunions avec les agences
Market access stratégie, HTA (Health Technology Assessment) …
To define development and registration strategies (Road-Map) in order to bring projects from device stage to drug-device combination medicinal product in accordance with regulatory requirements (EU/US).
Emerging pharmaceutical company who has developed a needle-free injection system to develop a pipeline of high value “supergenerics”, based on well-known injectable drugs (e.g. methotrexate, epinephrine, sumatriptan).
- Definition of CMC, non-clinical and clinical development road-maps for registrations trategies (EU, US);
- Design of bridging studies required for registration (e.g. Toxicology, PK/BE, human Factor);
- Preparation of scientific advice meetings (FDA and national agencies) including administrative application, briefing package writing and coordination of the meeting ; ) ;
- Networking and outsourcing project management of development phase with relevant CDMO and Experts ;
- Writing of IMPD/CTA, Orphan Drug Designation dossier and CTD dossier (M1 to M5 Dossier) ;
- Ad hoc supportive consulting activities and recommandations ;
Request for eligibility to PRIME (PRIority MEdicines) scheme to EMA .
Request for ODD status in EU in a rare condition affecting some patients with metastatic cancer
Within a challenging Timeline.
A North American biotechnology Company developing a new class of breakthrough drugs to treat brain diseases and brain-related disorders.
- Recommandations on regulatory strategy for PRIME and ODD applications ;
- Preparation and submission of PRIME Dossier ;
- Preparation and submission of ODD Dossier ;
- Project management in close interaction with sponsors and Health authorities ;
To validate the development plan (CMC, non-clinical and clinical) and propose a registration strategy at national and European level.
A biopharmaceutical company which develops and commercializes a range of innovative passive immunotherapeutic solutions based on specific polyclonal immunoglobulins [F(ab’)2] in the field of emerging infectious diseases.
- Critical review and recommandations on the development plan : CMC, non-clinical and clinical ;
- Preparation of scientific advice meetings (EMA and national) including administrative application, briefing package writing and coordination of the meeting ;
- Recommandations on registration strategies (e.g. Exceptional circumstances / compassionate use / orphan) ;
- Writing of CTD Dossier : M1 to M5 ;
To provide long-term CMC Regulatory support as a team member within several project development teams:
Recombinant toxins, radionuclide conjugated peptides and NCE (New Chemical Entities).
A worldwide biopharmaceutical company leader in specialty healthcare solutions with two innovative and differentiated technological platforms, peptides and toxins (recombinant and non recombinant).
- Definition of the CMC regulatory strategy (road-map) for clinical trials and MA applications ;
- Preparation of CMC parts of regulatory submission (e.g. IND/IMPD, MAA/NDA/BLA) ;
- CMC-Regulatory team representative within the company project organization ;
