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    Use this helpful scorecard, “How Are You Doing? Rate the Health of Your Business,” to measure 36 key indicators of a successful, highly
    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
    profitable business. You’ll test your business in the key areas that affect income, expenses, and production.

    -- Learn exactly where y
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    our business excels and what areas need improvement.
    -- Find new areas you haven’t thought about before, but could use to gain a
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    competitive edge.
    -- Use the survey results to create a plan to get your business to the next level – and beyond!

    Rate The Healt
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    h of Your Business

    Small to mid-size business owners, branch office managers, and independent agents, rate the state of your business d
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    uring the past 12 months.

    Rating System 1 = disaster 3= average 5 = brilliantly successful

    _________ Attracting Ideal Clients
    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
    _________ Customer Retention
    _________ Business Plan Effectiveness
    _________ Marketing Plan Effectiveness
    _________ Bra
    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
    ding/Identity
    _________ Sales System
    _________ Advertising Efforts
    _________ Networking & Follow-up Process
    ________
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    _ Profitability/Cash Flow
    _________ Pricing Process/Marketing Funnel
    _________ Availability of Capital
    _________ Strategi
    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
    c Alliances
    _________ Delivery of Services
    _________ Speaking Engagements
    _________ Products/Intellectual Property
    _
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ________ New Services
    _________ Administration Functions
    _________ Strong Competitive Edge
    _________ Elevator Speech That
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    Works
    _________ Status in Industry
    _________ Technology/Automating
    _________ Budgets & Reporting Processes
    _______
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    __ Internet Presence
    _________ Ongoing Internet Marketing
    _________ Controls/Procedures
    _________ Contracts, Legal Advice
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin

    _________ Hiring Process/Manual
    _________ Team(s) Development
    _________ Training, Cross-training
    _________ Employee
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    Consultant Retention
    _________ Office Organization
    _________ Computer Organization
    _________ Your Professional Developmen
    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
    t
    _________ Having Fun
    _________ Work/life Fulfillment
    _________ Setting Life Priorities & Goals

    Scoring: Since you mus
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    t consider all the above in your successful business/unit, it's not the total number that counts; it's how well you do in each area!

    Co
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ngratulations! You've now assessed the "state of your business." Now you know where your business excels and where it needs some work. I
    .

    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
    f you're ready to grow your business to the next level and truly change the state of your business in the next twelve months, it's time
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    to create recreate your business and marketing plans. Use the information you've gleaned to make sure that the next 12 months are great


    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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