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
Commissioning & Qualification
Logistica
Maintenance & Engineering
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
