New Chemical Entities, Recombinant Proteins, Targeted Therapies, Orphan Diseases,
Managing projects over time, anticipating difficulties, evaluating the results, establishing academic and industrial partnerships: on every mission we mobilize the best internal and external expertise in close cooperation with your project team.
For each project, we set up a multidisciplinary team that supports either certain specific stages of the development or the project in its entirety.
GLOBAL DEVELOPMENT STRATEGY
Define target product profile
Design of development plan (Road-Map)
Risk Management / QbD
Design of scientific studies
Global regulatory strategy
PROJECT MANAGEMENT AND COORDINATION OF STUDIES
Selection of CMO / CRO partners on tender
Audits / Coordination of partners
Coordination of development studies
Quality review of protocols and reporting
Budget monitoring / Planning / customer reporting
Investigator brochure and dossier for clinical trials (IMPD/ IND)
Orphan Drug Designation
Paediatric Investigation Plan (PIP/PSP)
MAA / NDA / BLA dossiers
PRIME procedure / Fast track
RELATION WITH THE HEALTH AUTHORITIES
Organization of scientific advice and pre-submission meeting
Interaction with agencies during the procedure (EU/US/Export)
Market access strategy, Health Technology Assessment (HTA) …
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 ;