Patient safety is our priority
Comprehensive solutions for drug safety management
Our team of pharmacovigilance experts offers multidisciplinary support throughout the entire drug lifecycle, ensuring regulatory compliance and the highest level of patient safety protection.
Clinical Research
Line Activation
Regulatory Approvals
Manufacturing
Distribution
Logistica
VALIDATION
Logistica
Maintenance & Engineering
EXCELLENCE AND FLEXIBILITY AT YOUR SERVICE
Our approach combines specialized expertise with adaptability to your needs. The team integrates regulatory, medical, and scientific knowledge to deliver tailored solutions that ensure regulatory compliance and strict adherence to timelines.
Our ability to manage drugs, medical devices, supplements, and cosmetics with equal efficiency allows us to adapt to the diverse needs of companies.
Integrated and specialized services
Pre-Market:
- Sponsor Registration in EudraVigilance
- Preparation, review, and updating of the Safety Management Plan (SMP)
- Case submission management during clinical trials
- Entry and updating of medicinal products in XEVMPD
- Drafting, review, and submission of the Annual Safety Report (ASR)
Post-Market:
- Provision of the Qualified Person for Pharmacovigilance (QPPV/Deputy QPPV) and Local Contact Person for Pharmacovigilance (LCPPV)
- Review and updating of the Pharmacovigilance System Master File (PSMF)
- Post-marketing case management and reporting (Data Entry, Quality Control, Medical Review, submission to EudraVigilance)
- Literature monitoring (national and international scientific journals)
- Preparation, review, and updating of Safety Data Exchange Agreements (SDEA) with third parties
- Preparation and updating of Periodic Safety Update Reports (PSUR) and Risk Management Plans (RMP)
- Signal detection and management
- Drafting, review, and updating of Standard Operating Procedures (SOP) and Working Instructions (WI)
- Medical Information services
- Conducting Pharmacovigilance Audits in accordance with GVP
- Activation, monitoring, and maintenance of the EudraVigilance profile
- Internal and external Pharmacovigilance Training
- Materiovigilance (Medical Device Vigilance) and Phytovigilance
Training and continuous support
In addition to operational support, our goal is to transfer knowledge through targeted training programs, enabling clients to progressively develop autonomy in managing their pharmacovigilance activities.
FAQs
How do you ensure continuity of service in case of unforeseen events?
We handle every unforeseen event with a flexible organizational approach and an efficient resource replacement system. Our team is structured to always ensure adequate coverage of activities, thus guaranteeing operational continuity without interruptions even in emergency situations.
What type of training do you offer to client companies?
We offer customized training packages tailored to the specific needs of our clients. Our goal is to support clients in growth and development through targeted, high-quality training that combines theoretical aspects with practical applications, enabling effective implementation of the acquired knowledge.
How do you manage the transition when you take over responsibilities previously handled internally or by other providers?
We have developed a structured phased transition process that minimizes risks and ensures continuity of activities. This includes an initial assessment of existing processes, identification of potential gaps, a detailed transition plan, and an overlap period to ensure complete transfer of knowledge and responsibilities.
Are your services available to companies of all sizes?
Absolutely. Our offering is modular and scalable, adaptable to the needs of both small start-ups and large multinationals. We customize our services based on the specific requirements, size, and resources of the client.
How do you ensure compliance with frequent regulatory updates?
Our team regularly participates in update courses and continuously monitors communications from regulatory authorities. We promptly implement every regulatory change in our processes and proactively inform clients about the necessary adjustments.
What are the typical response times for managing a pharmacovigilance case?
Our response times align with regulatory requirements, which vary depending on the severity of the case. For serious adverse events, we ensure processing and submission to authorities within the prescribed regulatory timelines.
How do you manage pharmacovigilance for products marketed in multiple countries?
We have a network of local experts who understand the specific requirements of each country. This allows us to ensure compliance with local regulations while maintaining a global and consistent approach. Our centralized system enables efficient management of cases from different geographic regions, ensuring an integrated view of product safety.
Is it possible to request pharmacovigilance services for limited periods, such as during activity peaks or specific projects?
Certainly. We offer flexible solutions that can be activated for specific periods based on client needs. Whether it is temporary support during high workload periods, coverage during staff absences, or assistance with specific projects like PSUR preparation, we can adapt our services to your contingent requirements.
