We are specialised in Regulatory affairs, Training, Consultancy, Pharmacovigilance, Medical devices, Food and Software development.
FDMIC maintains a dynamic, lean, highly skilled and very creative core team of professionals who work virtually and remotely from liaison offices in Europe, USA, and Middle East.
Each of our principal consultants has spent many years working in the pharmaceutical industry, regulatory agencies and/or academia and is a specialist in her/his area.
eCTD training and individual workshops for existing eCTD regions
Validate and repair eCTD/NeeS/VNeeS submissions to receive agency approval
eCTD 4.0 readiness workshop
Bring your existing NeeS submissions into eCTD
Ready for GCC VNeeS submissions
Build your eCTD submissions
Submit your eCTD submissions to Regulatory agencies
Learning Objectives
Identify fundamental strategies for preparing eCTD submissions
Learn Best practices
Explain the technical requirements
Build a VNeeS, an eCTD
Build a Variation
Build a Baseline
Learn top errors to avoid
Validate your submission
Who should Attend?
Submissions Management
Pharmacists
Authors of CTD Sections
Project Management
Documentation Teams
Regulatory Affairs
Regulatory Operations
Technical and Clinical Writers
Information Technology and Information Systems
Visiting the Office
The company is located at:
Office n° 1809, bayswater by Omniyat
Business Bay, Dubai
PoBox 309071,UAE
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Office n° 54, Building 315
Diplomatic area 317
Manama, Kingdom of Bahrain
Connect with Us
Connect Us Today for More Info - (973) 3399 9044