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    Small business owners come in several shapes and sizes. Some are solo-preneurs; others have a professional practice with five employees. Yet,
    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
    others have fifty employees, sell a single product and make millions. What many of these business owners have in common is that once upon
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    a time they had a dream. For some of them, their dream was never realized, at least not in the way they wanted.

    Why wasn't it realized, you
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    wonder.

    It might be that their business is not real. A bold statement but one you must ask if you want to be successful.

    Here is an oppor
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    unity to ask the question, "Is my business for real?" If your business is not as satisfying as you want it to be, take a moment, sit down and
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    think before you respond to any of the questions.

    The "Is Your Business for Real?" Quiz

    Answer Yes or No to the questions below.

    1. _____ D
    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
    o you own a real business or are you just working for a paycheck?

    2. _____ Does your business provide you with financial freedom?

    3. _____
    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
    Are you in charge of your business?

    4. _____ Do you have all the clients you want?

    5. _____ Are they the right clients for you?

    6. _____ Are
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    you excited each and every day?

    7. _____ Is your cash flow what you want?

    8. _____ Does your business bring you joy?

    9. _____ Are you contrib
    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
    uting at the highest level?

    10. _____ Are you totally satisfied?

    11. _____ Do you have a vision for your business?

    12. _____ Did you answer t
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ese questions truthfully?

    Now what? If you answered Yes! to more questions than you answered No, then having a Vision with a Capital V™ may
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    be an added value to your business success. If you answered No! to any of the above questions, get out your note pad and start taking actio
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    n.

    My message about having a really big Vision is different in that if you have a Vision With a Capital V, you will:

    * Focus on the inner yo
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    u and your business that helps to prevent overwhelm, loneliness and insecurity.

    * Clearly define who you really are, the service that you t
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    uly provide, as well as the people you want in your life.

    * Help yourself eliminate anything standing in the way of attracting the design f
    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
    or your perfect life and business.

    * Be guided to determine the qualities, values and principles required for your Vision.

    * Be directed you
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    to create your Vision with a Capital V™ that inspires and motivates you.

    * Assist you with supportive methods for defining and attracting
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    hat you want.

    * Provide you with insights, tools and strategies to keep your vision alive.

    If you want clarity of intention as well as the a
    .

    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
    bility to refocus your business and your life, it is time to act. Review your life purpose, your business purpose to see if they are in alig
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    nment. If not, reevaluate how you want your business to be. Maybe you just need a bigger and better vision to align your life with. Do it now


    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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