EXPERTISE

 

 

 

 

  DRUG DEVELOPMENT

 

  • Market positioning strategy for the « targeted product », versus disease, existing market, similar product already under development
  • Design CMC, preclinical & clinical development plan until registration encompassing regulatory pre-requisites
    • Advice on pre-requisites linked to the stage of development
    • Identification of subcontractor for drug substance and drug product manufacturing for GMP and GLP studies
    • Identification of subcontractor for non-clinical GLP studies
    • Identification of subcontractor for clinical studies
  • Support for the preparation of packages for agency meetings and/or investors

 

  EUROPEAN REGULATORY AFFAIRS

 

DEVELOPMENT

  • Regulatory strategy, advice & regulatory roadmap
  • Advice, preparation, compilation and submission to Competent Authorities/EMA of:
    • Clinical Trial Application (CTA)
    • Scientific Advice for EU Regulatory Agencies
    • Orphan drug designation (ODD)
    • Pediatric investigational plan (PIP)
    • Early access request in France (ATU)

REGISTRATION

  • Regulatory strategy
  • Coordination, review, compilation & submission of CTD dossiers for EU registration (MRP, DCP, CP)
  • Meetings with Agencies
  • Responses to Agencies questions
  • Review of CTD sections
    • CMC, pre-clinical & clinical,
    • Risk management plan
    • SmPC, labelling & package leaflet
    • Risk analysis and gaps identification of MAA dossiers

REGULATORY MAINTENANCE

  • Coordination, review, compilation & submission
    • Variations
    • Renewals
    • PSURs/PBERs
  • CMC compliance
  • Gap analysis
  • Update of CTD sections

PHARMACEUTICAL RESPONSIBILITY – SPECIFIC SUPPORT IN FRANCE

  • Compliance of Promotional activities:
    • Control of advertising and sales promotion
    • French sunshine act (DMOS)
    • Advice in the certification of sales representatives (Charte de l’information)
  • Advice, preparation, compilation and submission of “Exploitant” dossier
  • Quality Management for “Exploitants” in France
    • Gap analysis
    • Review & update of SOPs
    • Audits for “Exploitant” activities
  • Provision of a deputy Chief Pharmaceutical Officer (“Pharmacien Responsable intérimaire” – PRI)

 

  PROJECT MANAGEMENT

 

  • Development roadmap, strategic input of projects in development
  • Elaboration of global R&D plan and budget
  • Management of global R&D projects, internal and external, from late stage research to market
  • Project Leader to take projects from research to clinical POC
  • Plan and track project timings & cost. Issue warnings and correct when needed
  • Manage Due Diligence up to a recommendation
  • Management of CMOs & CROs
  • MAA dossiers preparation (regulatory, scientific writing & publishing)

 

  SCIENTIFIC WRITING

 

DRUG DEVELOPMENT

  • Investigational Medicinal Product Dossier (IMPD), Investigator Brochure (IB)
  • Development Safety Update Report (DSUR)
  • Briefing document for EU/US scientific advice
  • Orphan Drug Designation (ODD) dossier
  • Paediatric Investigation Plan (PIP) dossier
  • ATU dossiers (France): medical justification & protocol for therapeutic use (PUT)

REGISTRATION

  • CTD sections (CMC, pre-clinical, clinical)
  • SmPC, labelling & package leaflet
  • Risk Management Plan (RMP)
  • Responses to questions (RtQ)

MAINTENANCE

  • Periodic Benefit-Risk Evaluation Report (PBRER/PSUR)
  • Update of CTD sections (CMC, pre-clinical, clinical)