SDEA Management and Regulatory Consultancy
Pharmacovigilance
Safety Data Exchange Agreements (SDEAs) are critical legal documents that define the responsibilities and timelines for exchanging pharmacovigilance data between partners, such as MAHs, CROs and other stakeholders. Proper management of SDEAs is essential to ensure compliance with global pharmacovigilance regulations and maintain patient safety.
PVpharm provides expert support in the development, negotiation, and maintenance of Safety Data Exchange Agreements (SDEAs) in compliance with EU GVP Module VI and FDA guidance.
Our services include:
- Drafting and reviewing SDEAs: in line with EU GVP Module VI, FDA guidelines, and other international regulations
- Customization of agreements: to fit specific operational needs and regulatory obligations
- Training and advisory services: to enhance your internal understanding of SDEA best practices
