CDSCO Authorized Agent Support

BIOLOGICAL

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    CliniExperts will be the sole entity to look ensure your potential growth in the Indian market by assisting in licensing and registration processes, reaching out to distributors, providing logistics, guiding in pre-certification and post-marketing surveillance processes. Significant issues like delay in customs, inability to change distributors and others will be taken care of by our CliniExperts team.

    Authorized Agent For
    BIOLOGICAL – Overview


    A foreign company who doesn’t have its establishment in India, wants to enter India market, then they can appoint an authorized agent to register and market their products in India.

    An “Authorized Agent” means a person or entity in India authorized by the foreign company. The authorized agent will be responsible for the import and business activities of the foreign company in India including compliance to the provisions of the Drugs and Cosmetics Acts in all respects.

    Authorized Agent must possess a valid wholesale license meant for the sale and distribution of products or services in India and should be able to file an application to Central Licensing Authority for Biological registration in India.

    Who Would Need
    An Authorized Agent Service?


    Any foreign company who want to capture the Indian market but does not have its business operations or partner in India.

    Services CliniExperts Provides As An Authorized Agent

     

    Biologicals are agents extensively used in various aspects of patient care. They are used in diagnostics, therapeutics, preventive care and for improving patient life. Biologicals include serums, vaccines, r-DNA, stem cells, antigens, antioxidants and more. The seasoned team of CliniExperts enables manufacturers to register, import and distribute biologicals following every regulation and guideline laid down by the Indian authorities. CliniExperts can streamline all processes starting from the documentation to the distribution of the specified biologicals. CliniExperts holds a valid Authorized Agent registration certificate that can make your entire experience hassle-free. Having been in the field for over a decade, CliniExperts provides you services like:

    Guidance with Registration Process and Application

    Obtaining NOC for a global clinical trial

    Obtaining Authorization from CDSCO

    Obtaining Test License (Pre-Certification)

    Post Approval Changes

    Marketing Authorization

    Clinical Trial Permission depending on Phases of Trials.

    Responsibilities of
    Authorized Agent

    An Authorized Agent takes care of all the biological products' Import, marketing, distribution, and sale.

    The Authorized Agent must have a valid Wholesale Drug License to conduct the above duties

    The Authorized Agent will fulfill all the responsibilities and tasks to be carried out under the rules and amendments laid down by the government.

    The Authorized Agent takes the approval from the Ministry of Health and Family Welfare via application under Form-40 for grant of registration certificate (RC). The validity of the Registration Certificate is for three years.

    The agent must pay the necessary RC fees to the Licensing Authority.

    The Authorized Agent will manage the approval of clinical trials, marketing authorization and submit the application for RC to the Central Licensing Authority.

    The Authorized Agent will be legally responsible for intimating the CDSCO for any changes post approval on the site/drug in the registration certificate.

    The Authorized Agent will be responsible for issuing of Form-9 to the importers to import the drug on RC. An Authorized Agent will also assist in managing adverse reaction reporting and post-marketing surveillance.

    Essential Tips

     

    Two main requisites while preparing for the process of license application are:

    Possession of wholesale license for sale and distribution of biologicals in India


    Appointment as an authorized agent

    Expert Advise

    With respect to import of biologicals, the foreign manufacture has to submit

    Free Sale Certificate of their finished product in the GHTF countries

    Power of attorney, allowing authorized agent to market their products in India on their behalf

    The documentary evidence need to be submitted to the central licensing authority at the time of grant of license and subsequently as and when needed.

    Primary Service

    Wholesale License (Form 20B, 21B)

    Regulatory Body: SLA   Application Forms: Form 19

    CliniExperts offer strategic planning services during product registration in addition to finding distributors and acting as an authorized agent in India. Our hand in glove approach ensures that at no point you find yourself battling with any process by yourself.


    Who Can Apply

    The applicant who wishes to store, distribute and sale the drugs in wholesale cn apply for wholesale License. The person should be a Registered pharmacist (RP) who have a degree or diploma in pharmacy from a recognized university or competent person (CP). Further, arrange one person with same competency for it.

    Frequently Asked Questions

    Why do I need these services?

    Any foreign brand, manufacturer or distributor of biologicals products has to go through a rigorous registration procedure and approval process. At CliniExperts, we are a one-stop solution for possible issues that might arise during the process of registration and marketing of biologicals in the country. CliniExperts will take care of your biologicals, starting from registration in the Indian market to its sale, distribution and marketing authorization.

    What are the benefits to hire you in place of my distributor in India?

    Hiringa distributor can be complicated in the initial stages of business. In addition, theinability to change distributors, and their poor reach to the Indian market can be a hassle. In future, if you consider changing your distributor due to any reason, it will be a tedious process. CliniExperts is a leading regulatory and business consultancy in India; foreign companies can quickly register their products under the CliniExperts umbrella. Setting up a business in another country can be tedious, complicated and an expensive affair. CliniExperts is like a one-time investment for your all needs, as it will be a neutral point of contact between you and distributors. Through CliniExperts you can change multiple distributors or choose your distributor based on your specific requirements, as your business expands, instead of hunting for new or more distributors repeatedly. We can provide expertise and help streamline your yearly annual compliances, accounting and penalties. Moreover, we understand the Indian market and its norms and regulations; the CliniExperts team can guide you in keeping up with the latest taxation policies, closure causes and complexities of rules in India.

    What additional services you are offering along with these services?

    CliniExperts helps its clients by providing assistance and expertise in the following services:

    • Obtaining NOC (Form 29) ·
    • Approval for Clinical Trials ·
    • Expert Marketing business strategy for Biologicals ·
    • Obtaining Authorization from CDSCO ·
    • Assisting in post-approval changes ·
    • Identifying potential distributors area-wise and state-wise to launch your products in India.
    • A warehouse and CFA support for the distribution of your product
    • Import assistance and customs clearance support [Post-market surveillance and Pre-certification support]

    What sales model are you offering?

    The main focus at CliniExperts will be increasing your reach to the Indian market; we will be a significant neutral and common point of contact for all licenses, registrations, imports, and distribution of your product. In addition, our highly experienced team can provide seamless logistic support and analysis. They will be available round the clock to provide you with optimum services.

    What is the legal compliance to opt for these services?

    As an appointed Authorized Agent, CliniExperts will be legally responsible for pre-certification and post-marketing surveillance inquiries. Any product recall, adverse drug reaction, or compensation to be made, or legal compliance will be covered by the actual manufacturers to CliniExperts.

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