We provide end-to-end regulatory support for domestic and international submissions, helping sponsors navigate applicable regulatory requirements across different markets. Our services include regulatory documentation, submission preparation, and coordination to facilitate efficient and compliant approvals.
GLOBAL SUBMISSIONS
MDL collaborates with global partners across the UK, European Union, and Africa, enabling access to diverse clinical research capabilities, expertise, and regional networks. Through these partnerships, we support the delivery of high-quality, globally relevant clinical research and regulatory solutions.
PHARMACOVIGILANCE
We provide comprehensive pharmacovigilance and drug safety services across the product lifecycle, supporting robust safety surveillance and regulatory compliance. Our capabilities include ICSR processing, signal detection, and safety reporting, including PSUR/PBRER and DSUR preparation, supported by experience with industry-standard safety and medical terminology tools.
Tools & Expertise: Oracle Argus, ArisG, Veeva Safety, and MedDRA.