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    We rarely come across instances, wherein small businesses have successfully transformed themselves into large corporations with operations spread across, unl
    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
    ess of course they are merged with or acquired by a giant. Rather such occurrences are so rare, that they have been noted down in various journals as importa
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    nt case studies. But, what if this exceptional growth pattern was to become a norm? Why can’t an aspiring entrepreneur so often convert the desires into hard
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    -core business?

    The key factor has been the lack of strategic planning at the grass root level. Small businesses either think that they are too small to act
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ually undertake diligent strategic planning or if at all they realize the requirement, lack of apt knowledge and guidance does not enable right strategy to b
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    e planned let alone implemented.

    Strategic Planning: Requirements and Implementation Strategic planning is at the heart of any business. Any unplanned or n
    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
    umerous circumstantial moves can only result in a short-term endeavor. Long-term survival, associated growth and profits are they key fundamentals of any bus
    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
    iness decision. Strategic planning not only decides a course of action for any enterprise but also provides for contingency planning and solutions.

    Various
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    small business even if understand the importance of strategic planning in the overall functioning, fail to implement it in their model. The reasons could be
    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
    many; ranging from poor planning to lack of communication and employee support.

    An important fact to be recognized here is that employees are the actual str
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ength of any venture. The Director alone cannot run a business. Therefore to implement strategic planning, or any other decision, in the true sense of the te
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    rm make sure that your employees understand the overall need and their role.

    Therefore, while jotting down the key essentials for implementation of strategi
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    c planning in small and large business alike a foremost requirement is complete executive and employee support.

    To enable commitment on the part of your emp
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    loyees make sure that they understand the overall requirement of any decision and its correlation to the planning. Additionally they must be clearly abreast
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    of their individual role in the overall strategy as devised.

    This can be achieved by fulfilling the second most crucial requirement of implementation of str
    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
    ategic planning i.e. Effective Communication with all the involved. Make sure that the communication channel is two-way and the associated can understand the
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    message as intended.

    Any planning initiative relies heavily upon the basic inputs i.e. extensive internal and external research in terms of your own capabi
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    lities and market trends and analysis.

    Therefore, the third crucial aspect that must be considered for devising and implementing strategic planning is organ
    .

    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
    izational ability and competitive analysis.

    Any organization can stand only on the pillars of meticulous strategic planning followed by equally committed im
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    plementation. Therefore, whether small or large, one must understand and appreciate the importance and corresponding need of planning in the business model.


    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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