Within the pharmaceutical industry, an increasing number of agreements with third party companies exist, like in-licensing, out-licensing distribution agreements, co-marketing of medicinal products and other PhV service providers. However, responsibilities for safety data collection, documentation and reporting are not always clearly defined and divided between the parties entering such business arrangements although the Marketing Authorization Holder must be compliant with current pharmacovigilance and regulatory requirements.

Our Services:

• putting in place Safety Data Exchange Agreements (SDEAs) to ensure safety data is collected and handled correctly
• Offer support or templates for different SDEAs set-ups with your company partners in the context of shared MRP/DCP procedures, out-licensing, distribution or co-marketing of medicinal products and PhV service providers

• maintain an overview on existing SDEAs and responsibilities set-out in the contracts