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).
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 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
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
