Implant & develop

your activities in France 

Tailor-made support for your activities in France.

Implant & develop your activities in France

Tailor-made support for your activities in France.

How can we help you ?

EXPLOITANT SUPPORT

PROMOTIONAL ACTIVITIES AND REGULATORY COMPLIANCE

  • Promotional and training documents review
  • New campaigns implementation
  • Submission of health care professional and consumer promotion authorization requests as well as renewals
  • Advice and audit on activities linked to the promotional information charter

QUALITY

  • Exploitant site: dossier for site opening, change of address, modification
  • Quality Management System of Exploitant site:
    • Advice, redaction and procedures updates
    • Audits on the exploitant activities

Provision of a deputy Chief Pharmaceutical Officer (“Pharmacien Responsable intérimaire” – PRI) and of a qualified person responsible for Pharmacovigilance (RPV).

PHARMACOVIGILANCE

PHARMACOVIGILANCE

QUALITY MANAGEMENT SYSTEM OF PHARMACOVIGILANCE

  • Advice on the system organization
  • Procedures redaction and updates, SDEA, PSMF
  • Pharmacovigilance system audits and subcontractor’s audits
  • Audits for pharmacovigilance system and partners

PHARMACOVIGILANCE RESPONSIBILITY

  • Availability of local qualified person responsible for Pharmacovigilance responsible (local QPPV) and EUQPPV
  • Transition management
  • Advice on pharmacovigilance regulation

REDACTION AND REVIEW OF SAFETY DOCUMENTS, RMP, PSUR/PBRER, DSUR, AMRR

EARLY ACCESS AND COMPASSIONATE USE

  • Advice and strategy
  • Pre-submission meeting support
  • Redaction and constitution of the dossier (including the therapeutical use protocol)
  • Follow-up on the early accesses: modifications, renewal, synthesis reports
  • Global project management
  • Taking into account the issues of the common law file

earlY ACCESS

EARLY ACCESS AND COMPASSIONATE USE

  • Advice and strategy
  • Pre-submission meeting support
  • Redaction and constitution of the dossier (including the therapeutical use protocol)
  • Follow-up on the early accesses: modifications, renewal, synthesis reports
  • Global project management
  • Taking into account the issues of the common law file

earlY ACCESS

REGULATORY AFFAIRS

REGULATION ANALYSIS

OPERATIONAL SUPPORT IN FRANCE

  • Marketing Authorization (MA) dossier: new MA, variations, renewal
  • Switch dossier to over the counter, free access.

SCIENTIFIC REDACTION

  • Investigational Medicinal Product Dossier (IMPD), Investigator Brochure, Risk Management Plan, CTD modules

REGULATORY AFFAIRS

REGULATION ANALYSIS

OPERATIONAL SUPPORT IN FRANCE

  • Marketing Authorization (MA) dossier: new MA, variations, renewal
  • Switch dossier to over the counter, free access.

SCIENTIFIC REDACTION

  • Investigational Medicinal Product Dossier (IMPD), Investigator Brochure, Risk Management Plan, CTD modules