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  • Digg It - 6 Symptoms of a Company in Crisis

    Is your company in a crisis? Not sure? Check out the list below to see if you need to take action now!

    Denial
    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
    ockquote> You have been warned that there are problems in the company. It doesn’t matter what kinds of problems there
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    re—cash connected, poor collections, declining sales, increased defects if you’re a manufacturer, reports of terrible c
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ustomer service, and on and on. Denial will kill your company. Get some help—fast. Cash Problems
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    The checkbook and company savings account (if there is one) are decreasing every month. Your internal accou
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    nting person is on you every day to do something. But there are so many fires, and so many incoming phone calls houndin
    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
    you that you are virtually paralyzed. Vision Failure
    Somehow you and your team lo
    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
    st track of what business you’re in. It was clear when you began the company, and that continued for many years but you
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    have to admit that today’s vision is really vague and hazy now and since your market has changed and the times have cha
    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
    nged you’re lost. Customer Confusion
    As hard as it is to admit to this issue you ack
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    owledge that no one in your company has any idea what your customers want and hope to get in the coming years. The sad,
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    hard truth is that your marketing and sales people simply aren’t doing their jobs. Nobody in your company ever asks yo
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    r customers what they want from your company. A simple question that most always will result in clear answers.
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    kquote> No Strategic Planning
    You don’t have a business plan. There is no written strategic bluepr
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    nt that offers a track for the company to run on. Why not? Usually the answers range from “no time to do one, who would
    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
    do it, no one here is capable, we know what to do… writing a plan would just be a waste of time.”

    Inc
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    pable People
    Loyalty is impressive and respected but if the wrong people inhabit your company you’re r
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    eally in trouble. Speak to a well-qualified labor/employment attorney about steps you must take to remove people who ar
    .

    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
    hurting you and the company. It may take time but no company will ever reach its potential by keeping inferior people
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    on the payroll. If this is your company, it is time to take action! Contact Gene Pepper at the link below


    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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