Regulatory End-to-End Activities

We, PharmaMEA, offer comprehensive support throughout the regulatory affairs journey, from initial consultations to post-approval activities. Our services cover a wide range of regulatory activities, related to OTC and prescription drugs of various dosage forms. It includes:

Regulatory Submissions (CTD and regular);

Efficient Review (CMC/Quality/Clinical/Non Clinical) and Approval Processes;

Post-Marketing Surveillance Solutions;

Labeling Updates and Life Cycle Management;

Regulatory Compliance;

Renewals and Variations.

Contact our specialists to tailor a service plan

Regulatory Affairs