Safety Data Exchange Agreements (SDEA)

Whenever safety responsibilities are shared — with license partners, distributors, co-marketers or vendors — a Safety Data Exchange Agreement defines who does what, by when. Gaps or ambiguities here are a frequent inspection finding, because a missed obligation between two parties is still the MAH's failure. PharmExpert drafts, reviews and manages SDEAs (PV agreements) that are clear, compliant and workable.

We map the partners and the safety responsibilities shared with each, then draft SDEAs that define roles, reconciliation, and reporting timelines unambiguously — or gap-analyze your existing agreements against GVP and against how they actually operate in practice.

Workability matters as much as compliance. An SDEA that looks complete but cannot be executed day to day will fail at the seams, so we ensure timelines and reconciliation processes are realistic and that oversight mechanisms are genuinely usable.

For organizations with many partners, we build templates and an SDEA register so agreements stay consistent and maintainable as the network grows, and we support audit and inspection readiness for the SDEA framework. The result is shared safety responsibility with no gaps for obligations to fall through.