Notre mission principale, vous accompagner dans les activités de l’Exploitant et Distribution Médicaments, DM, Compléments alimentaires
Nous vous apportons notre expertise et expérience :
- Sur l’ensemble des activités réglementaires « Exploitant/Distribution Médicaments-DM-Compléments alimentaires » et de la vie de vos produits et de leur environnement : du conseil à la prise en charge globale
- Sur les procédures spécifiques à l’exploitation d’AMM
ODD
QPPV
PIL
RMP
CTD
IMPD
MA
IMPD
eCTD
ODD
QPPV
CTD
PIP
CTD
PSUR
PIL
RMP
EXPLOITATION
Dossier d’ouverture d’établissement pharmaceutique – Etats des
LieuxModifications et fermeture de site Exploitant
Mise à disposition de Pharmacien Responsable Intérimaire (PRI)
Audits et préparation d’inspections – sites Exploitant – Suivi des actions correctives – inspections ANSM
Mise en place d’un système Qualité (SMQ) pour un site Exploitant
Analyse qualité des Revues Qualité Produits
Rédaction de procédures/Manuel Qualité/Flux organisationnel
Promotion et Publicité : validation éléments promotionnels et d’information – soumission
Préparation et suivi de la Certification de la Charte de la Visite Médicale
Loi Encadrement des Avantages ou LAC
Modules de formation (en lien avec les activités de l’Exploitant)
VIGILANCE
Mise à disposition d’EUQPPV et local QPPV
Audits et préparation d’inspection en pharmacovigilance, matériovigilance, nutrivigilance
Conseils en cosmétovigilance et nutrivigilance
Suivi des actions correctives – Inspections ANSM
Rédaction des PSMF et SDEA
Modules de formation en vigilance
Rédaction et revue de procédures
LIFECYCLE MANAGEMENT
Stratégie d’enregistrement (Enregistrement, Lifecycle)
Variations /DMI (RCP, Notice, Etiquetage…)
Renouvellement d’AMM
Audit Qualité des Dossiers AMM
Conseil réglementaire spécialisé
Rédactions de modules, Compilation, Formatage et Soumission de dossiers en e-CTD
Préparation et coordination des réponses aux questions des Agences
Test de lisibilité des notices
ASMF (Conseil à la rédaction)
Tranferts d’AMM (Titulaires, Exploitants, Sites)
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 ;
