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    STRATEGIC CONSULTING

    1. Commercial brokerage:

    In the trend of integration and development, pharmaceutical manufacturers want to develop their products on a global scale and at the same time, distributors in Vietnam want to look for reputable manufacturers to supply. good quality products.
    However, cultural differences and legal issues have always been a major barrier for foreign businesses to start developing businesses in Vietnam. Especially the difficulties in enforcing the regulations in the health sector – an area with many specific characteristics.
    With nearly 10 years of experience in the pharmaceutical industry and high expertise of a team of Pharmacists and Lawyers, Thien Thao Pharma is the bridge between global manufacturers and importers and distributors in Vietnam.

    2. Update information, change:

    During the circulation of finished drugs, health food, cosmetics, medical equipment, the registration establishment and the manufacturer responsible for bringing the product to the market should be considered. engineering, as well as making any necessary modifications so that drugs are manufactured and controlled based on generally approved scientific methods. These changes must be approved by the regulator.

    Thien Thao Pharma always accompanies customers in the process of drug circulation in Vietnam and updates the changed information, drafting, and fully completes the modified and supplemented dossier at the request of the management agency.

    3.Track and report ADR:

    Pursuant to Circular 32/2018 / TT-BYT dated November 12, 2018 on Regulations on registration of circulation of drugs and medicinal ingredients, the establishment of registration of drugs and medicinal ingredients needs to cooperate with Drug manufacturers, importers and distributors shall monitor, supervise, collect, synthesize, evaluate and send reports to the National Center for Drug Information and Adverse Drug Reaction Monitoring ( The National DI & ADR Center) informs about post-vaccination and adverse drug reactions in accordance with Clause 5, Article 77 of the Law on Pharmacy, Guidelines for Good Pharmacovigilance Practices, National guide to pharmacovigilance and related regulations.
    The drug registration establishment must make reports on safety and effectiveness assessment every 6 months within the validity of the valid registration certificate and send it to the National DI & ADR Center for synthesis, evaluation and reporting to the Department. Pharmacy Management.
    Thien Thao always accompanies customers in the circulation of drugs in Vietnam and coordinates with drug manufacturers, importers and distributors to monitor, supervise, collect, synthesize, evaluate and Submit a report to the National Center for Drug Information and Adverse Reaction Monitoring.

    4. Consulting GPs:

    Pursuant to Circular 36/2018 / TT-BYT Regulations on Good Storage Practices for Medicines, Medicinal Ingredients, Good Storage Practices for Medicines and Medicinal Ingredients (GSP – “Good Storage Practices”), is the principles and standards on the storage of drugs and medicinal ingredients to ensure and maintain the best safety and quality of drugs and medicinal ingredients through adequate control throughout the storage process. .
    Applying the principle of “Good storage practices for drugs” applicable to all units manufacturing, trading, importing, exporting, trading in and storing drugs, providing drug storage services, and pharmaceutical departments. hospital, research institute and medical center
    Consulting process to assess response to Good Storage Practices for Medicines and Medicinal Ingredients (GSP)
    The team of pharmacists and lawyers at Thien Thao is always confident to provide customers with the best quality and most prestigious GSP consulting services.

    5. Intellectual property consultancy:

    Pursuant to the Law on Intellectual Property of Vietnam, passed by the 11th Vietnam National Assembly at its 8th session on November 29, 2005, “Intellectual property rights are rights of organizations and individuals over property. intellectual property, including copyrights and related rights to copyright, industrial property rights and rights to plant varieties ”.
    The growing industry of pharmaceutical and healthcare products in Vietnam requires businesses to have a unique identity for themselves as well as their products. Understanding that need, Thien Dropoc provides intellectual property consultancy services to pharmaceutical businesses and businesses trading in health care products.

    Intellectual property consultancy services at Thien Thao include:
    • Registering trademark
    • Registration of industrial designs
    • Patent registration
    • Franchising
    Pursuant to the Law on Intellectual Property of Vietnam, passed by the XIth National Assembly at its 8 session on November 29, 2005.
    • Trademark is a sign used to distinguish goods and services of different organizations and individuals.
    • Industrial design is the appearance of a product represented by shapes, lines, colors or a combination of these factors.
    • An invention is a technical solution in the form of a product or a process that is intended to solve a specific problem by applying laws of nature.
    “Commercial right” includes one, some or all of the following rights:
    (Decree No. 35/2006 / ND-CP detailing the Commercial Law regarding commercial franchising)
    a) The right to be allowed by the franchisor and to require the franchisee to conduct the business of providing goods or services by itself under a system specified by the franchisor and affixed to the trademark, the name of the franchisor. trade, business slogans, business logos, advertising of the franchisor;
    b) Rights granted by the franchisor to the franchisee for primary commercial rights;
    c) The right to be re-granted by the secondary franchisor to the secondary franchisee under a joint commercial franchise contract;
    d) Rights granted by the franchisor to the franchisee under the commercial right development contract.

    6.Clinical trial consultation:

    Thien Thao cooperates with domestic and foreign companies to provide clinical trial research services in Vietnam.
    • Register to research and complete products from steps 1-4
    • Feasibility study and hospital selection
    • Project management, clinical research monitoring
    • Drug safety and pharmacovigilance

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