Pharmaceutical Establishment – France

Our consulting firm provides you with expertise in the organization and management of pharmaceutical Establishments, ensuring full compliance with current French regulations.

Pharmaceutical Establishment – France

Our consulting firm provides you with expertise in the organization and management of pharmaceutical set-ups, in accordance with current regulations in France.

Pharmaceutical Responsibilities

Exploitant sites

Manufacturing sites

Targeted support for pharmaceutical activities

For wholesalers and for manufacturing sites

  • Guidance on establishing or optimizing a wholesaler’s Quality Management System

  • Preparation of Dossier for new licenses or modification to existing pharmaceutical establishment authorizations

  • Support with drafting and submitting the annual Site Master File

  • Preparation for and follow-up of regulatory inspections
  • Regulatory compliance assistance: review of printed packaging components, promotional materials and submission of the PM and GP advertising authorization

  • Support and guidance for the Product Quality Review (PQR)

  • Provision of a deputy chief pharmaceutical officer*

*COCIPHARM CONSULT provides you with a deputy chief pharmaceutical officer, who can be listed in Section B as described in Article R5124-36 of the French Public Health Code (CSP).

Pharmaceutical Responsibilities

MANUFACTURER

  • Manufacturing operations
  • Quality control
  • Batch certification

  • Storage management

exploitant (wholesaler)

  • Storage and distribution

  • Batch traceability and product recall

  • Medical information

  • Pharmacovigilance activities

  • Advertizing compliance, product quality complaints

Expertises

Expertises

Oversight of pharmaceutical responsibility and partner follow-up

Design and monitoring of Quality Management Systems

 Preparation and management of regulatory inspections

Market surveillance and product lifecycle tracking

Corinne CIAPPARA

CMC Consultant & Director

330 boulevard de la Madeleine

06000 NICE – France

info@cocipharm-consult.com

+33 (0)6 81 41 68 16

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