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    Strategic planning helps organizations to focus on their energy, to ensure that employees are working towards the same goals
    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
    , performing in improved ways. Strategic planning helps to assess and adjust a firm's direction in response to a changing en
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    vironment. It is a disciplined effort to make basic decisions and actions that shape and guide what an organization is, what
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    it does, and why it does it. Strategic planning is a process that helps organizations to envision their future and develop
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    essential steps and actions towards it.

    1. What are the basic steps in strategic planning process?

    The basic steps involve
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    d in a strategic planning process are statements of vision, mission, values, assessment, goals and objectives, strategy and
    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
    outcome. Gathering and analyzing information, identifying serious issues faced by the organization, development of a strateg
    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
    ic vision, mission review or revision and development of strategic goals and strategies are implicated.

    2. What is a missio
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    n statement?

    A mission statement outlines customers, competitors and markets. It defines business scope and purpose. It set
    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
    s customer requirements and the range of services provided. The mission statement answers the question 'What is our future b
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    usiness?'

    3. What is a vision statement?

    A vision statement describes the desired future structure, services, size and mar
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    kets. It is rather a sketch than a blueprint. It describes basic features and not specific dimensions. It can be called the
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    strategic baseline, and it has to be challenging and compelling. An effective vision statement makes you different. It is si
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    gnificant and substantive. An effective vision statement captures the dream of the organization.

    4. Does a highly successfu
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    l company require strategic planning?

    An organization being successful means that it has a sound and appropriate strategy.
    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
    But there is no guarantee that it will continue to be so in the future. There are many examples of once successful companies
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    that failed because they stuck with a once successful strategy that became inappropriate later.

    5. Does a smaller or simpl
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    er organization really require strategic planning?

    Yes, it does. It should be noted that smaller or simpler organizations h
    .

    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
    ave less tolerance for misapplying their limited resources than larger organizations. So the need for strategic planning in
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    smaller or simpler organizations is higher. Smaller and simpler organizations require smaller and simpler strategic planning


    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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