Pharmacovigilance: Patient safety is our priority.

Our support in drug development

Development

Marketing Authorization

Market Access

Maintenance

Study of development plans for clinical trials (submission of IMPDs and INDs and selection and management of third party suppliers)

Management of registration procedures and response documents: drafting of the CTD and electronic submission

Market access consultancy and strategies (study of early access programs, P&R management, preparation and negotiation of the dossier)

Management of changes, renewals, promotional materials, medical information and pharmacovigilance activities

Il nostro supporto

Development

Marketing Authorization

Market Access

Maintenance

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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.

WE ARE regulatory business experts FOR CLINICAL STUDIES AND life science products

Comprehensive solutions for drug safety management

AN organized TEAM FOR EVERY NEED

EXCELLENCE AND FLEXIBILITY AT YOUR SERVICE

Integrated and specialized services

Un supporto continuativo su tutto il lifecycle management

Pre-Market

Un supporto continuativo su tutto il lifecycle management

Post-Market

Training and continuous support

How do you ensure continuity of service in case of unforeseen events?

What type of training do you offer to client companies?

How do you manage the transition when you take over responsibilities previously handled internally or by other providers?

Are your services available to companies of all sizes?

How do you ensure compliance with frequent regulatory updates?

What are the typical response times for managing a pharmacovigilance case?

How do you manage pharmacovigilance for products marketed in multiple countries?

Is it possible to request pharmacovigilance services for limited periods, such as during activity peaks or specific projects?

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