Services

• Pharmaceutical Analytical and QA Consulting
• Pharmaceutical Product Development Consulting Services
• Pharmaceutical Regulatory Affairs Services
• Pharmaceutical Toxicology Consulting
• Scientific and Medical Writing Services
• Expert Witness and Intellectual Property Support for Pharmaceuticals
• Regulatory Electronic Submission Publishing Services

Pharmaceutical Analytical and QA Consulting

Pharmaceutical Analytical Consultancy skills used to product development and Quality Assurance (QA) processes, based on years of global experience meeting pharmaceutical regulatory standards.

Pharmaceutical consulting services from Smart Medical Solutions can be hired on their own or in conjunction with research projects. Typically, consulting programs are tailored to meet the needs of specific clients and can range in size from small to large.

Pharmaceutical Product Development Consulting Services

Supporting the pharmaceutical product development process with consulting, strategy, and documentation services.

From lead candidate selection to final regulatory submissions and post-market operations, Smart Medical Solutions can assist your organization in formulating development strategies for pharmaceutical and medical products. Our worldwide perspective and scientific skills can help you achieve success by making your development program more efficient and manageable.

Pharmaceutical Toxicology Consulting

Toxicology consulting services for the pharmaceutical business on a global scale.

Pharmaceutical, biotechnology, and medical device firms benefit from Smart Medical Solution's experienced toxicological and regulatory consulting services. Through the combined expertise of scientific and regulatory professionals situated across the world, Smart Medical Solutions experts with years of industry experience provide solutions to challenging development, toxicological, and regulatory concerns.

Scientific and Medical Writing Services

From nonclinical, peer-reviewed publications through regulatory submissions and clinical documentation, we provide scientific and medical writing services.

Smart Medical Solution's medical and pharmaceutical professionals have a wide range of scientific expertise and vast experience in pharmaceutical development, allowing them to write clear and simple documentation for medical and pharmaceutical companies . We can generate a wide range of medical and pharmaceutical documentation to meet the needs of many stakeholders, including clinical investigators, IRBs, medical monitors, study coordinators, and regulatory reviewers, based on our industry expertise and regulatory interactions.

Expert Witness and Intellectual Property Support for Pharmaceuticals

Expert witness services and pharmaceutical exploratory analyses to help pharmaceutical intellectual property protection

Expert witness services, intellectual property development, registration, and protection are all important parts of the pharmaceutical business model. Incorporating unique excipients or innovative formulation designs that give useful release characteristics or aid control stability to a medicinal product are examples of intellectual property in modern pharmaceutical products.

Sophisticated characterization techniques and a robust analytical methodology are necessary to support intellectual property protection, or to verify that one is not infringing on a Patent. Our experienced team, which comprises internationally acknowledged leaders in their scientific domains with many years of experience in helping to solve the most complicated analytical challenges, uses a wide range of chemical analysis and imaging techniques to conduct these investigative investigations.

Our Expert Witnesses have played a vital role in deciding the outcome of several judicial issues in which the authenticity of complex data and its interpretation was a key component in determining the case's outcome. Pharmaceutical analysis scientists at Smart Medical Solutions provide skilled chemical analysis and imaging services to help clients comprehend and visualize complex pharmaceutical compounds. Through our Total Quality Assurance expertise, we assist our clients in their intellectual property protection efforts, assisting them in overcoming legal and commercial problems.

Regulatory Electronic Submission Publishing Services

For the pharmaceutical and healthcare industries, Smart Medical Solutions provides full end-to-end Regulatory Electronic Submission Publishing services, specializing in eCTD publishing.

Regulatory authorities all across the world mandate electronic submissions for a variety of regulatory submission types. Our team of skilled, experienced specialists routinely generate compliant, "first-time-right" submissions ranging from modest to big and complicated dossiers or applications, utilizing industry-leading eCTD publishing tools and supporting several

international companies. Every contribution goes through a multi-faceted quality control review procedure to ensure completeness and compliance with electronic submission requirements.

Pharmaceutical and Medical Device Regulatory Affairs Services

Regulatory Affairs consultancy services for the pharmaceuticaland medicalDevice industries.

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.

Pharmaceutical and Medical Device Regulatory Affairs Services:

1-Regulatory Strategy, Gap Analysis & Classifications

Drugs, Biologics, OTC Products, Combination GSL Products, Medical Devices for professional and consumer use , cosmetics , food and Disinfectants.

2-Submission Dossier Preparation

Submission to the related health authority ( MOH-AP , Dubai Municability , ESMA , MOIAT , Department of health Abu dhabi and Dubai Health authority ).

3-Label and PIL Preparation & Review

Product Monographs, Package Inserts, Container Labelling, OTC Product Labelling Preparation and Review as per the UAE latest regulations

4-Regulatory Agency Interactions Support

Consultation, Understanding the Clients needs, Meetings and Follow up

5-eCTD Publishing& Technical Support

eCTD submission publishing, Electronic Submission Gateway and technical support For Conventional submission in UAE .

6-Expedited Approval Pathways

Regulatory support and preparation of Fast Track Innovator Pharma products, Breakthrough Therapy and vaccines.

7-Quality Control Lab testing Locally in UAE In approved labs

Support in lab testing for the Conventional,GSL , Medical Device , Consumer , cosmetic and food categories .

8-Marketing Applications

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)

9- Pharmacovigilance Support( PV)

PV officer Nomination for UAE MOH-AP as per the Guideline , PV Consultation service PSUR , Adverse events reporting and product recall in UAE market .

10-Latest UAE Guidelines

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.

11-Coding, Serialization, GTIN Code and GLN code

As per the new MOH-AP Guideline we can support the pharma companies to comply with Tatmeen Project on UAE-MOH-AP

12- Consulting

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.

13 - Categories of products on scope

• Pharmaceutical products registration ( Innovators , Generic , Biological , Biosimilar )
• General Sales Products (Dietary supplement , Medicated Cosmetic, Antiseptic and Disinfectant , Miscellaneous)
• Medical Device ( Professional use medical device , consumer medical device , Dental instruments and related materials , Lab Instruments and related Reagents ) , Medical Equipment’s , Medical Software and IVDs and Disposable Medical products )
• Cosmetics ( Face and body care items , disinfectant , makeup , perfumes , ….)
• Food Registration

14 - Logistic Support

Support the clients to get import permit request and clear their products safely

15-Local representative support

Local representative support for the pharma and medical device companies to present them with the Governmental authorities

16- Agents Supporting Service to enter UAE Market

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 .