Pharmacovigilance

Gap Analysis, Strategy & Training:

As you expand your product portfolio, it’s crucial to ensure your pharmacovigilance system is robust and compliant. We conduct thorough gap analyses, identifying gaps in your current PV system and developing cost-effective, compliant solutions. Our experts provide tailored training for your teams and external partners such as distributors, and ensure your pharmacovigilance processes are in full alignment with global regulations. We also help implement fully compliant pharmacovigilance databases to support your growing needs.

• Identify system gaps and design tailored solutions
• Training for internal teams and external partners e.g. distributors
• Implement fully compliant pharmacovigilance databases for growing needs

Pharmacovigilance Implementation:

Agos Pharma offers end-to-end support for your pharmacovigilance system, from initial case processing to compliant regulatory submissions. Whether you are in the pre-marketing phase or post-marketing phase, we offer services across the EU, UK, and USA to ensure global regulatory compliance. Our experts manage aggregate reporting and harmonise data across multiple CROs to ensure smooth and compliant PV processes.

• Pre-marketing case processing and reporting
• Full regulatory support and expedited electronic reporting
• Aggregate reporting and data harmonisation across multiple CROs

"One-Stop Shop" for Pharmacovigilance across Multiple Studies:

Using multiple CROs across studies can mean variable quality and costs, especially for small to medium-sized pharma and biotech companies. Aggregate reporting can be more complicated when using more than one service provider and this can make it difficult to manage your own safety database. We can provide a one stop shop for all your studies.

Safety Support During Clinical Development:

Throughout all stages of clinical development, we offer comprehensive safety support, including Serious Adverse Event (SAE) management, safety database implementation, and expedited Suspected Unexpected Serious Adverse Event (SUSAR) reporting. Our services also include providing safety physicians, as well as preparing essential Development Safety Update Reports (DSURs) to ensure compliance and timely reporting.

• SAE management and expedited SUSAR reporting
• Safety database implementation and management
• Provide safety physicians and prepare DSURs

Preparation for Market Authorisation

As you prepare for your Marketing Authorisation Application (MAA), we offer expert support in developing your pharmacovigilance system and preparing your Pharmacovigilance System Master File (PSMF), ensuring full compliance with European and UK regulations. We can assist with Risk Management Plans (RMPs), and assist with identifying, screening and onboarding EEA QPPVs and local contacts.

• Develop compliant pharmacovigilance systems and prepare PSMFs
• Risk Management Plans (RMPs) and EEA QPPVs provision