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  • E-Folder - Running a Small Business - The Seven Fatal Mistakes

    The failure rate for young small businesses is apallingly high. Any business is definitely a risk. But your chances of success will be dramatically increased i
    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
    f you aviod these seven fatal mistakes.

    1. Inexplicitness.

    Succes in business and life has never been achieved through vagueness. Explicit objectives are the
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    drivers of achievement. Setting out clear goals for your business allows you to develop strategies to achieve your goals and to create plans which will ultimat
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ly drive your business to success. Without goals, strategies and plans, you are just depending on luck- and how has that worked for you so far?

    2. Apathy.

    Fe
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    human activities require a greater commitment than operating a business. Success without commitment just doesn't happen. And apathy for your business will mea
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    commitment is impossible. Commitment requires passion. You are the closest person to your business, and if you are not passionate about it, why would your emp
    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
    oyees or customers be? If you aren't passionate about what you are doing, find something that you are passionate about and do that instead.

    3. Pride.

    Pride i
    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
    your business is a good thing, but being so proud that you don't ask for advice or help will seriously limit your ability to grow. No-one knows it all. Succes
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ful business owners surround themselves with smart people.

    4. Inactivity.

    If you are waiting for others to recognise your brilliance, you may be waiting a lo
    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
    g time. Business is generated through taking action. And the best idea in the world just remains an idea until someone takes action on it. There is no return f
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    om inactivity.

    5. Non-perseverance.

    Giving up at the first hurdle will never result in success. The chances of success with out some dispappointments are low
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    Thomas Edison tried 10,000 different filaments before he invented the light bulb. Perseverance is essential for success.

    6. Guessing.

    If you do not measure
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    he response of each action and tactic of your business, from marketing to service delivery, you are just guessing about what is working and what is not. Withou
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    good data on your performance, your choices between what you should fix, and what you should leave alone will be random, and end up demoralising you and your
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    taff. And while you are guessing, your competitors are improving through measuring their activities, and leaving you behind.

    7. Disorganisation.

    If there is
    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
    o organisation in your business, you will have no control over your expenses, you will lose efficiency, and your clients will go to someone who can provide rel
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    able service. Systems ensure that your services are provided consistently following your best practice, no matter who is providing your service. They eliminate
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    the cost of non-compliance, and ultimately create a saleable asset of your business. Without systems, your business will always depend on you being there and y
    .

    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
    u will forever be reacting to events and fighting fires. Such a business has no long term future.

    I am sure you can think of other sins you may wish to add to
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    this list, however when you make sure that you don't commit any of these, your business is far more likely to achieve the goals you have set for it and prosper


    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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