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  • Advice You - Franchisor Policies for Unlicensed or Sold Territories

    Franchisors often have issues when they own a brand which has service vehicles; where franchisees wish to operate in non-franchise
    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
    assigned territories. We had this as a re-occurring issue in our franchise system. We came up with this policy, which is also in
    ; 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 Confidential Operations Manuals. Here is a sample policy for our franchisees:

    “Unlicensed Areas”

    “If you are called into an
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    unlicensed territory for service, you may service that particular client. You will obviously pick up additional clients in those
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    areas from referrals, leads and people who see the truck. It’s ok to service these customers. However, you must:

    Not have over
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ne-third of your clientele out of your exclusive territory

    Give up these clients if we sell that adjacent territory to a new fran
    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
    chisee

    You must let us know which other area you are working in

    We don’t recommend washing cars outside your exclusive territory
    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
    because it will cost you many hours in travel time over the course of a week. Fifteen minutes here, twenty minutes there. It ad
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ds up, trust us. We have assigned you an exclusive area, which will more than suffice. After all:

    You know the area

    You live i
    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
    n the territory

    You have a perfect mix of business

    We spent money marketing that area

    If you are occasionally called to a non-a
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    signed or unlicensed territory and you find another franchisee is also working that area, it’s ok to split the area amongst yourse
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    lves with the understanding that which ever buildings/customers they were doing prior to your coming in that area you should honor
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    . You and the other franchisee might both have to give up those customers if we sell or assign that territory and retreat back to
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    your exclusive territory. Be advised that this can happen and it has before. If these customers you have been servicing are ver
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    y important to you, you may want to purchase that additional area. We of, course, would love for you to have this as part of your
    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
    exclusive territory because you are one of our best franchisees. Contact your regional director to start the negotiation process
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    And, by the way, don’t bring your attorney to the negotiations. This is a very informal procedure.

    We are all on the same team
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    . If you can handle the additional customer demand and our staff likes you, I’m sure we can negotiate a fair deal for all concern
    .

    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
    ed.”

    If you are a franchisor of a home based or service franchise system you must address this situation or you might wind up in
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    court defending what is generally understood by all parties anyway. Think about this and get your policy ready and let it be known


    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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