Drafting, review, and negotiation of Safety Data Exchange Agreements (SDEAs) to ensure clear roles, responsibilities, and compliance with regulatory requirements.
Direct liaison with partners and vendors to establish and maintain effective SDEA processes and communication channels.
Ongoing monitoring of SDEA compliance, including periodic audits and performance reviews.
Development of SDEA templates tailored to your business and regulatory needs for efficient agreement management.
Continuous monitoring and implementation of regulatory changes affecting SDEAs to ensure ongoing compliance.
Preparation for regulatory audits and inspections related to SDEA processes and documentation.
Support for SDEA requirements across multiple countries and regions, ensuring seamless global compliance.
Ongoing support for continuous improvement of your SDEA processes and documentation.