Consulting in Vigilances
Our expertise at your service
With an extended experience of French, European and International Vigilances gained over 20 years in major pharmaceutical companies, Marta Gersberg Consulting offers a personalized support tailored to your needs.
Our goal is to assist you in achieving your missions of Vigilances:
- PHARMACOVIGILANCE:
- Medicines and products for human use
- Medicines and products for veterinary use
- MEDICAL DEVICES VIGILANCE
- COSMETOVIGILANCE
Through the application of rigorous methods, the expertise in guidance and project management, Marta Gersberg Conseil helps you to adapt to the continued evolution of the regulatory environment in the areas of Vigilances.
Our services are designed to achieve your missions of Vigilances and to assist you in the completion of your projects.
Who are we?
Our physicians and pharmacists have acquired an extended experience over more than 20 years in the field of pharmacovigilance and its regulatory environment, in major pharma corporates and their subsidiaries.
- An experience recognized within the pharma industry, for the high quality of their services in all areas of Vigilances.
- A constant monitoring of the environment and a continuous training of our team.
- A commitment to quality, responsiveness and scientific integrity in achieving our expertise in Vigilances.
Our services
Ours services are proposed according to your expectations and your specific needs.
They are elaborated according to the current national, European and international regulations, within the required formats and methods, in English, French or Spanish. We guarantee the respect for deadlines in the delivery of our services.
Pharmacovigilance
Implementation and optimisation of your pharmacovigilance system
- Choice for a pharmacovigilance system adapted to your company, full assistance until its implementation
- Optimisation of your existing system
- Recruitment of your employees
Our commitments
Compliance of your pharmacovigilance structure to existing regulatory requirements, at national, European and international level.
Quality Management System
- Development of a new pharmacovigilance system master file (PSMF), or peer review of your existing system
- Writing or revising of your standard operating procedures, work instructions and forms
- External audits of your pharmacovigilance system (affiliates and corporate, business partners, subcontracting companies, distributors, promoting agents)
- Inspections of the Regulatory Authorities: documentary preparation and team coaching
Our commitments
Fulfillment of the documents to the standards of quality and to your company standards.
Constant training of our team to the latest regulatory texts.
Respect for the deadlines in the delivery of our services.
Safety reports
- Fulfilment of current national and European regulations in the preparation of expertise reports on your medicinal products, i.e.
- Periodic safety update reports (PSUR/PBRER), risk management plans (RMP), periodic safety reports in the context of temporary authorisations and/or recommendations for use (ATU and/or RTU), or compassionate use, cumulative analysis for « dossiers de transparence » or clinical overview
- Reply to the requests of national or European Health Authorities:
- European Medicines Agency (EMA), Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), Agence Nationale de Sécurité Sanitaire de l’Alimentation, de l’Environnement et du Travail (ANSES), l’Agence nationale du médicament vétérinaire (ANMV), other national competent authorities
Our commitments
Fulfillment of the safety reports to the standards of quality, to your company standards, and to your product portfolio.
Quality control of the documents by setting up adapted tools.
Respect for the deadlines in the delivery of our services.
Non-interventional studies, registries, post-approval named patient use programmes and studies on the use of medicinal products
- Preparation of Standard Operating Procedures on collection of adverse events in the context of non-interventional studies
- Search for unidentified adverse events
- Preparation of reports according to the protocols and to the regulatory requirements
Our commitments
Fulfillment of the safety reports to the standards of quality, to your company standards, and to your product portfolio.
Compliance with regulatory requirements in the preparation of quality documents on the collection of adverse events.
Control of the exhaustiveness of the collection, notably regarding not reported serious adverse events.
Pharmacovigilance training
- Building tailor-made modules of training:
- for in-service training of your employees
- for implementation of the new pharmacovigilance regulation
- Pharmacovigilance training at your offices
Our commitments
Solid and operational training in accordance with current legal framework and good pharmacovigilance practices, tailored to the public specificities: physicians, pharmacists, scientists, clinical research associates, sales representatives, distributors, promotion agents, and more.
Pharmacovigilance Medical Devices Cosmetovigilance
Medical Devices Vigilance
Implementation and optimisation of your medical devices vigilance system
- Select a medical devices vigilance system adapted to your company and full assistance to its implementation
- Optimisation of your existing system
- Recruitment of your employees
Our commitments
The compliance of your structure of medical devices vigilance to existing regulatory requirements, at national, European and international level.
Quality of your medical devices vigilance system
- Development of a new medical devices vigilance system, or peer review of your existing system
- Writing or revise your standard operating procedures, work instructions and forms
- External audits of your medical devices vigilance system (affiliates and corporate, business partners, subcontracting companies, distributors, promoting agents)
- Inspections of the Regulatory Authorities: documentary preparation and team coaching
Our commitments
Fulfillment of the documents to the standards of quality and to your company standards.
Constant training of our team to the latest regulatory texts.
Respect for the deadlines in the delivery of our services.
Cosmetovigilance
Implementation and optimisation of your cosmetovigilance system
- Select a cosmetovigilance system adapted to your company and full assistance to its implementation
- Optimisation of your existing system
- Recruitment of your employees
Our commitments
The compliance of your structure of cosmetovigilance to existing regulatory requirements, at national, European and international level.
Quality of your cosmetovigilance system
- Development of a new cosmetovigilance system, or peer review of your existing system
- Writing or revise your standard operating procedures, work instructions and forms
- External audits of your cosmetovigilance system (affiliates and corporate, business partners, subcontracting companies, distributors, promoting agents)
- Inspections of the Regulatory Authorities: documentary preparation and team coaching
Our commitments
Fulfillment of the documents to the standards of quality and to your company standards.
Constant training of our team to the latest regulatory texts.
Respect for the deadlines in the delivery of our services.
Contact us
For an expertise in Vigilances, for a personalized support and custom-made service, for a public call for tender or for any other inquiries, please contact us:
- By email: info@mgersbergconseil.com
- By phone:
Phone: +33 (0) 1 39 52 94 53
Mobile phone: +33 (0) 6 77 02 38 22
Fax: +33 (0) 1 39 52 95 93 - By post:
Marta Gersberg Conseil
7, rue Marcellin Berthelot
78400 Chatou
France