Welcome to FDM International Consultancy

We provide Consulting services to the Pharmaceutical industry and Regulatory Authorities.

The industry now faces the challenges of unpredictable product pipelines, increasingly competitive markets, and uncertain policy and regulatory environment.

eSubmission, eCTD

Our experts were members of the team who have built the eCTD specifications

This is the right place when you start dealing with full electronic submission services with regard to eCTD preparation, publishing and submission activities in Europe, US, Switzerland and GCC (Gulf Cooperation Council) countries.

Our dedicated team ensures the technical quality of the source documentation, the technical validity of the final submission package according to applicable global and regional eCTD specifications and requirements as well as the timely submission to the agencies via submission gateways.

Whether you need help in eCTD submissions, we are here to support you.

Our team also provides the following services:

Training Software eCTD VNeeS Build Submit

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

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.

Welcome to FDM International Consultancy

eSubmission, eCTD

Our team also provides the following services:

Visiting the Office