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    We cannot escape from the advancing globalization. Why to globalize or – seen more reg
    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
    ionally – internationalize ?

    Due to the permanently increasing competition a big number of
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    producers from ‘all over the world’ enters our market places. This narrows naturally the local market
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    for local producers because the clients very often only need less complicated machinery for their pro
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ucts/solutions and thus imported products are completely sufficient.

    On the other hand local manufac
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    urers very often offer technical products on a high standard which in-turn would be needed in other c
    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
    untries of the world due to their specific production methods/goals.

    Looking towards the huge indust
    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
    ialized European markets – from Italy to UK, from Poland to Germany - there exist enormous potentials
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    for foreign suppliers.

    In addition the manufacturers get direct information from the markets, the cl
    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
    ents’ needs as well as market trends which enables them to develop new solutions or to adapt their pr
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ducts – besides of the fact that they become more independent from the local/regional economic cycles
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    .

    The European markets have their own specific mentalities.

    Michael Richter, Daugendorf/Germany has
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    specialized in supporting foreign companies – especially SMEs – to conquer Europe (see http://www.mar
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    eting-und-vertrieb-international.com/en/exportregions-for-you.htm) and offers practical support in al
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    marketing tasks.

    Contact:

    Michael Richter

    Dreherg?ssle 5

    88499 Daugendorf/Germa
    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
    .

    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

    ichael.richter@marketing-und-vertrieb-international.de

    Phone: +49-7371-93210, Fax: +49-7371-9321


    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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