Smart Medical Solutions a Pharmaceuticals & Healthcare Regulatory Affairs team is a powerful scientific and regulatory consulting Company. We guide and assist pharmaceutical, biotech and healthcare companies in the design and implementation of innovative and global regulatory strategies in order to expedite product development and registration of drugs, biologics, medical devices, lab , dental, general sales, cosmetic , food products, and other healthcare products for all stages of development.
We are a team of experienced regulatory professionals in UAE who advise and provide regulatory support for products in all stages of development (preclinical to post-market). We collaborate with companies to bring products to UAE market in the most efficient and cost-effective manner, within an evolving and increasingly challenging regulatory environment.
Drugs, Biologics, OTC Products, Combination GSL Products, Medical Devices for professional and consumer use , cosmetics , food and Disinfectants.
Submission to the related health authority ( MOH-AP , Dubai Municability , ESMA , MOIAT , Department of health Abu dhabi and Dubai Health authority ).
Product Monographs, Package Inserts, Container Labelling, OTC Product Labelling Preparation and Review as per the UAE latest regulations
Consultation, Understanding the Clients needs, Meetings and Follow up
eCTD submission publishing, Electronic Submission Gateway and technical support For Conventional submission in UAE .
Regulatory support and preparation of Fast Track Innovator Pharma products, Breakthrough Therapy and vaccines.
Support in lab testing for the Conventional,GSL , Medical Device , Consumer , cosmetic and food categories .
We can support in preparing and get the Related government authorities’ approval for all the marketing material (Education health campaign, Press release,social media materials, and printed materials)
PV officer Nomination for UAE MOH-AP as per the Guideline , PV Consultation service PSUR , Adverse events reporting and product recall in UAE market .
We can provide the latest and most updated Guidelines related to Conventional, General sales, Medical device, Cosmetic from the registration and logistic point of view.
As per the new MOH-AP Guideline we can support the pharma companies to comply with Tatmeen Project on UAE-MOH-AP
Get on-demand expertise to better facilitate your business. Elevate your products, processes and people to new heights with Smart Medical Solutions as your service provider.
From meeting health, environmental and regulatory requirements, building safety and quality into the design process and product, targeting the companies that would like to enter to UAE market , and streamlining manufacturing practices, Smart Medical Solutions diverse range of consulting services can enhance your business.
In almost every industry imaginable, our consultancy services can halt issues before they become problems, provide innovative solutions to complex issues, suggest processes and procedures for optimised efficiency, and are proactive in helping to manage and assess risks and hazards.
Drugs, Biologics, OTC Products, Combination GSL Products, Medical Devices for professional and consumer use , cosmetics , food and Disinfectants.
Support the clients to get import permit request and clear their products safely
Local representative support for the pharma and medical device companies to present them with the Governmental authorities
If you are looking to have a UAE distributer to your products , Smart Medical Solutions can connect you with the market leader Distributer who can support you in marketing, distributing and logistic work .