MENA-GATE Group

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  • Our Services

    Our Services


    Providing the best solutions to access the opportunities

    Market Access Management

    Select the right market and the right partners; through our network we will direct you to a variety of potential and trusted partners will play a role in managing the communication and guiding you during the agreement negotiation process.



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    Providing the best solutions to access the opportunities

    Regulatory Assistance

    Overcoming complex regulations and access hurdles, shorten time to market and accelerated registration through our regulatory expertise all over the region will provide excellence in the process effectively and efficiently.



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    Providing the best solutions to access the opportunities

    Pharmacovigilance activities Management

    MENA-GATE Group can provide our specialised support to Marketing Authorisation Holders (MAHs) to meet the Good Pharmacovigilance Practice (GVP) Guidelines through various activities including:

    • Proper maintenance of the Pharmacovigilance System Master File
      (PSMF).
    • Taking over the Qualified Person for Pharmacovigilance (QPPV) and
      QPPV deputy roles.
    • Ensuring a functioning Pharmacovigilance system is in place for both business hours and out of hours collection.
    • Taking care of the data collection from various sources.
    • Compilation and regulatory submission of Risk Management Plans (RMPs) and subsequent implementation of applicable Risk Minimization
      Measures (RMMs).
    • Training personnel on Pharmacovigilance.
    • Providing our advice and support to MAHs while preparing for Pharmacovigilance Inspections and in the subsequent creation of necessary Corrective and Preventive Actions and their effective implementation.
    • Preparing and submitting Periodic Safety Update Reports (PSURs).



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    Providing the best solutions to access the opportunities

    Digital Solutions

    Digital solutions are no longer optional, companies must embed a digital-first approach into every facet of the business MENA-GATE Group helps the partners to grow in today’s hypercompetitive marketplace.

    MENA-GATE Group is ready to provide you with:

    • ERP.
    • CRM, CLM.
    • eCTD.
      Pharmacovigilance Software solution (PV-Pedia).
    • E-learning.
    • Online consultation solution for healthcare professionals.
    • Hospital management.
    • Health Insurance Management.
    • Waste management.
    • Webinars.



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    OUR SERVICES?


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  • Company Profile

    Company Profile


    Ready to help you
    We help
    pharmaceutical companies effectively and efficiently

    Professional team with a proven regional track record in leading multinational organization, with extensive experience and market Knowledge and eminent network with key player all over MENA region. our experiences in regional management, regulatory affairs, product licensing and distribution.

    MENA-GATE Group aims to help pharmaceutical companies effectively and efficiently in entering and exploring new opportunities in MENA region by providing a wide range of services and business models.

    Bridging the access gap, utilizing MENA-GATE Group regional network to partner with companies to seize the opportunities of entering the fastest-growing markets in the ME and North Africa Region with growing economies which are expected to grow rapidly in the next few years.

    MENA-GATE Group is relying heavily on our strategic selection of potential markets and successful partners locally and globally.

    MENA-GATE Group is committed to perform with integrity and according to local and international laws and regulations.



    Ready to help you
    Our
    Vision & Mision

    Our vision is to be the lead in offering market access management and solutions that are high in quality and proven to be effective and efficient in their practices.

    We aim to reduce the cost of healthcare while helping pharmaceutical companies improving the quality for the needs of the communities we serve.

    Our fundamental purpose is to help potential customers to be able to choose the best market through our global and local partners.

    Our Mission

    Our mission is to always improve the quality of services we provide and the quality of work for all our clients with our products and solutions.

    Clarity – We are focused on goals and results and assume responsibility for the tasks and projects that we take on.

    Loyalty – We want to represent and present our company positively to the outside world. Responsibilities and loyalty is a two-way street.

    Pride – We are proud of the company’s achievements and for being part of a team that benefits the people.

    Respect – We deal with each other in a respectful manner, and we welcomed diversity of opinion.


    List Of References

    1. Australia
    2. Austria
    3. Belgium
    4. Canada
    5. Denmark
    6. Finland
    7. France
    8. Germany
    9. Iceland
    10. Ireland
    11. Italy
    12. Japan
    13. Luxemburg
    14. Netherland
    15. Newzeland
    16. Norway
    17. Portugal
    18. Spain
    19. Sweden
    20. Switzerland
    21. United Kingdom
    22. United States

    List of reference BOOKS

    1. British-National-Formulary (BNF)
    2. Rote-list
    3. Vidal
    4. Compendium Swiss
    5. Orange Book
    6. FOOD AND DRUG ADMINISTRATION( FDA)
    7. Physician’s Desk Reference (PDR)
    • FDA: FOOD AND DRUG ADMINISTRATION
    • TGA: THERAPUTIC GOODS ADMIMSTIRATION
    • EMEA: EUROPEAN MEDICINES AGENCY
    • MHRA: Medicines and Healthcare products Regulatory Agency


    Our Teamwork
    Dedicated professional team

    Our team is the secret to our success. Each one is amazing in his own right, but together they are what makes our company such a fun and rewarding place to work.

    Our team is a talented group with a shared vision of delivering consistently great results for our clients, as well as ensuring MENA-GATE Group is a challenging place to work and develop a rewarding career.

    MENA-GATE Group has always been a company defined by bringing together talented people with a shared vision and passion for helping us to be the best we can be for our clients.

    All of our employees are unique individuals who are united by a set of core vision and mission that apply to everything we do within our company.