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    When I meet holistic professionals and ask them what they do, I hear a very different answer fro
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    m those experiencing success than from those who are struggling. The difference is not in what y
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    u offer, how much you charge or your experience and credentials. The difference I hear is in wha
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    is focused on in your answer.

    As a holistic professional, you know your business is not about
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ou. Your business is about the people you serve – your clients. So, when you answer the question
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    -- “What do you do?” -- your answer must also focus on your clients and not on you. If you answe
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    by describing your services, explaining the process of what you provide or sharing your knowled
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    ge, experience and education -- that is about you.

    Potential clients (as all people you meet ar
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    , either directly or as a referral source) do not want to talk about you. They want to know what
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    you can do for them. They want to know what results they will experience if they choose to work
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ith you. By speaking to their most challenging problems with your most effective results, you as
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ist them in knowing if they are interested in listening to you further. After prospects know you
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    understand their challenges and can help solve them, those other aspects then become important.
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    he key is not offering them too soon.

    There is a profound quote that says, “People don’t care h
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ow much you know, until they know how much you care.” This is even truer in business. When you c
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    nnect with potential clients on what is most challenging them, you show them you understand wher
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    they are coming from and that you get it. People don’t buy your services and they don’t choose
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ou because of your process or what you know. People buy your results. Your services, process and
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    experience only assist you in delivering those results.

    So, the next time you get asked -- “Wha
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    do you do?” -- I invite you to listen to how you answer. Remember

    Copyright 2005 Melissa Quite


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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