Training Programs
Enhance your team's regulatory expertise with our specialized courses.
Enroll Now
1
MODULE 1: REGULATORY AFFAIRS OUTLINE
Regulatory Affairs Overview and Drug development - 8 Hours
Guidelines and summary - 10 Hours
2
MODULE 2: DOSSIER REGISTRATION OUTLINE
CTD Document Preparation and submission - 240 Hours
Dossier summary (Mod 1 and 2) - 8 Hours
Life cycle Maintenance activities, including safety labelling - 30 Hours
Permit Application (normal, special permits and Clinical trial permits) - 10 Hours
Report writing, Reg intelligence and Client communication - 6 Hours
3
MODULE 3: DEVICE REGISTRATIONS, LISTINGS AND OTHER REGISTRATIONS
Medical Devices - 30 Hours
Registration Nutraceuticals / cosmetics - 10 Hours
Blood Products - 30 Hours
Herbal Registrations - 15 Hours
4
MODULE 4: GxPs
GxP and QMS, and Audit readiness - 15 Hours
GMP Application (Separate) - 2 Hours
5
MODULE 5: PHARMACOVIGILANCE
Pharmacovigilance and Post marketing surveillance overview - 15 Hours
6
MODULE 6: VET REGISTRATION
Veterinary product registration process - 240 Hours
Life cycle Maintenance activities, including safety labelling - 30 Hours
Listings VMD [Medical Devices and Nutraceuticals] - 6 Hours
7
MODULE 7: OPENING OF PORTALS
Portal opening and License processing - 1 Hour