- Implementation of
pharmacovigilance systems - Operational pharmacovigilance
activities - EU QPPV &
Local QPPV services - Pharmacovigilance
Training
We write Pharmacovigilance Standard Operating Procedures (SOPs), Working Instructions, and Safety Management Plans. We also handle the revision and update of existing procedures.
Design and Implementation of Pharmacovigilance Systems (PSMF)
We implement your pharmacovigilance system, including all necessary documentation such as the Pharmacovigilance System Master File, in compliance with both national and international regulations and standards. We also support its maintenance.
Preparation of Safety Data Exchange Agreements (SDEAs)
It is essential to develop agreements that define the responsibilities of each partner in relation to pharmacovigilance activities. A well-written agreement ensures regulatory compliance and prevents the duplication of pharmacovigilance activities by different partners. We can help you with this.
Adverse Event Management
We handle adverse events that occur during clinical studies as well as those reported post-marketing.
Literature Review
In accordance with current legislation, we develop a literature search strategy that is best suited to your product, enabling effective identification of adverse events that require management. We also gather all relevant information that may be useful for the preparation of safety reports.
Risk Management Plan Writing (EU RMP)
We write the Risk Management Plan required for the marketing authorization application. We can also ensure its update if needed.
Responses to Health Authorities’ Inquiries
When Health Authorities reach out with pharmacovigilance-related questions, we assist you in preparing the responses you need to provide them.
EU QPPV
We provide EU QPPV services as required by EU legislation and EU GVP Guidelines. The EU QPPV must reside in the EU, be permanently available, and have sufficient authority to influence the performance of the quality system and pharmacovigilance activities of the MA holder.
Local QPPV & Local Literature Monitoring
We offer Local QPPV services in France as well as in other countries, where we also ensure local literature monitoring.
Training Services
We provide training on all aspects of pharmacovigilance to either pharmacovigilance professionals or staff from other departments such as marketing and sales representatives. This is primarily done through workshops tailored to meet the specific needs of each client. We also provide training to investigators participating in clinical trials on adverse event reporting procedures.
Our values
Integrity
We act with transparency, ethics, and responsibility to ensure the reliability and compliance of our services.
Flexibility
We adapt to our clients’ needs with responsiveness and tailored solutions.
Quality
We guarantee rigorous services that meet the highest industry standards.
Transparency
We communicate clearly and honestly to establish lasting trust.
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Our mission
We ensure quality pharmacovigilance services by:
- Building a strong relationship with our clients based on trust and professionalism
- Working with passion and energy
- Continually developing our expertise in our field
- Ensuring regulatory compliance
- Delivering high-quality work
