At Dr. Mwiko Health Solutions Ltd, we provide end-to-end support in the development, implementation, and maintenance of Safety Data Exchange Agreements (SDEAs) ensuring that all pharmacovigilance (PV) responsibilities between partners are clearly defined, compliant, and effectively managed.
Whether you are working with licensing partners, distributors, contract manufacturers, clinical research organizations, or marketing authorization holders (MAHs), we help you establish robust agreements that guarantee timely and accurate exchange of safety information in line with regulatory expectations.
Our SDEA Services
- SDEA Authoring and Review
Drafting or reviewing SDEAs to clearly define roles, responsibilities, and timelines for safety data exchange, consistent with GVP Module I and local requirements.
- Gap Analysis and Harmonization
Assessing existing agreements for alignment with current PV systems, identifying compliance gaps, and recommending corrective actions.
- Negotiation and Finalization Support
Providing expert input during contractual discussions to ensure SDEAs are practical, compliant, and mutually beneficial for all partners.
- Implementation and Oversight
Supporting the rollout of SDEAs across affiliates and partners, ensuring that operational procedures (e.g., case reporting, aggregate data sharing, and signal management) are well integrated.
- Tracking and Lifecycle Management
Establishing tools and templates to monitor agreement status, version control, renewal timelines, and compliance with agreed safety exchange processes.
- Audit and Inspection Preparedness
Ensuring your SDEAs are inspection-ready, with clear documentation demonstrating effective oversight of partner relationships and safety data exchange practices.
Why Partner with Dr. Mwiko Health Solutions
- Regulatory Expertise: Deep understanding of regional and international pharmacovigilance legislation and industry standards.
- Tailored Solutions: Agreements customized to reflect your organizational structure, operational model, and global safety system.
- Transparency and Compliance: Our approach ensures smooth collaboration between all parties while maintaining compliance with applicable regulations.
- End-to-End Support: From initial drafting to training and ongoing management, we provide complete lifecycle support for SDEAs.
At Dr. Mwiko Health Solutions, we believe that strong partnerships are built on clarity and compliance. Our SDEA services safeguard your organization by ensuring that every stakeholder in your safety network fulfils their regulatory obligations thus protecting patients, products, and your reputation.
