New Chemical Entities, Recombinant Proteins, Targeted Therapies, Orphan Diseases,
Medical Device…
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.
ODD
QPPV
PIL
RMP
CTD
IMPD
MA
IMPD
eCTD
ODD
QPPV
CTD
PIP
CTD
PSUR
PIL
RMP
GLOBAL DEVELOPMENT STRATEGY
Define target product profile
Design of development plan (Road-Map)
Risk Management / QbD
Design of scientific studies
Global regulatory strategy
Some Case StudiesPROJECT 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
REGULATORY SUPPORT
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
Briefing package
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 ;
