Regional Regulatory Affairs, Support and Management
Our regulatory team has the necessary experience and know-how to facilitate study regulatory requirements throughout MENA region countries. Our matchless asset lies in the close and continuous interactions we have with local regulatory authorities allowing for timely resolution of regulatory affairs and study approvals. We also assist global research groups including international CROs and academic institutions with expediting their regulatory approval process or resolving any obstacles they may have incurred. Our regional affairs experts have the unique regional regulatory experience, which includes:
- Regulatory form submission translated in the appropriate language "dialect" for each MENA country
- Strong relationship with the regional regulatory authorities (regional FDA and MOH offices) in addition to distinctive knowledgeable of the latest regulatory practices and guidelines
- Extensive experience preparing the necessary documentation for regulatory bodies, local health authorities, and IRB and ethics committee.
- Provide a transparent assessment of regulatory approval timelines in addition to study-site qualifications and their approval processes