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  • Advice You - Outsourcing

    It’s about time someone spoke the truth concerning outsourcing. The politicians sure won’t. They prefer to do finger-pointing saying
    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
    it is “his fault”. It is those greedy manufacturers who want to make bigger profits by having cheap labor in Asia perform your task f
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    r less money.

    Did anyone ever tell you that if it wasn’t for outsourcing you might not have a job? Did anyone ever tell you that th
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    e underwear, shoes, jewelry and hundreds of other items you own would cost much more if it wasn’t for outsourcing? Probably not.

    Sur
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    , many tasks are being sent overseas. Why? Just because it is cheaper? No, because the manufacturer that item had to do it in order t
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    be able to compete with other companies making a similar product. If your company or any company cannot remain in business then they
    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
    will cease to exist and you will be out of a job. As a former manufacturer I will tell you it is dog-eat-dog out there and every com
    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
    any is doing its best to maintain sales and profits. The company did not go into business to make products and give you a job; they w
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    nt into business to make money and if they can’t do that they (and you) will be gone.

    Profits is not a dirty word. Again if it wasn’
    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
    t for profits you would not have a job. The guy who owns the small business or the thousands of stockholders who own the big companie
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    expect that company to make money or they will sell their shares and you will be gone too.

    When you work for someone you want to do
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    everything possible to contribute to their bottom line. Turning of the extra lights, keeping your machine properly maintained, gettin
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    g a shipment out to a customer even if it means staying a few extra minutes and many other little things that you know better than I.
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin

    Until about 1975 we did outsourcing and no one objected to it. The widget manufacturer stopped making screws and bought them from th
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    guy across town or in the next state who made exactly what he wanted and at a price cheaper than he could produce them in his widget
    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
    factory. Now we buy the screws from China and India at a price that is half or less than those made in the USA. If not each widget m
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ght cost dollars more and be enough to lose business to a competitor. If the widget company did not outsource there could be a strong
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    possibility they would go out of business. Outsourcing is not a U.S. phenomenon. It is happening to Canada, Germany, Japan, England,
    .

    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
    France, Australia and many other countries. Even Mexico is losing jobs to Asia because they can produce the same quality goods and s
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    rvices delivered here for less.

    Outsourcing is not only here to stay, but is going to expand as competition becomes even more fierce


    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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