Menu

Regulatory Affairs consultation and strategy development


a. Product classification
b. Product registration
c. Label validation and modification
d. Medical Translation (labels, artwork and Patient Information leaflet)
e. Product lifecycle management (variations and renewal)
f. Manufacture registration and renewal
g. Importation process approvals
h. Dossier preparation (CTD & e-CTD)
i. Laboratory Test and analysis
j. Drug store facility & approval
k. Pharmacovigilance: implementing a system relating to GCC’s MOH guidelines
l. Good manufacturing practice (GMP)
m. Marketing Advertising approval
n. Product trade mark protection and registration