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  • Business Articles - Ask Not What You Can Do for the Government; Ask What the Government Can Do for Your Business

    Women business owners are increasing substantially, and if they go through the proper channels there are several governmental organizations set up to play a support r
    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
    ole in helping those companies thrive. But as many things associated with state and federal governments, a slow-moving bureaucracy can bog down by the process.

    One o
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    f the biggest boons for women-owned businesses came in 1999, when Congress passes legislation that set aside contracts for women-owned companies in typically male-dom
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    inated industries. In addition, securing a federal contract can mean millions to a small and growing business. The legislation, however, hasn’t quite worked out as pl
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    anned.

    “The number of women-owned businesses is astounding,” Susan Phillips Bari, president of the Women’s Business Enterprise National Council told the Associated P
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ess in a recent article. “Our issue is not with the number of businesses, but rather with their access to contracts in the government and private sector.”

    The federa
    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
    l government’s pledge of awarding 5 percent of federal contracts to women-owned firms fell short in 2004, coming in at 3 percent. In percentages, that may seem like a
    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
    small number, but in dollars that number translates into the billions. Because of this shortfall, the U.S. Women’s Chamber of Commerce went to court last fall, and
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    won a hearing that demanded the Small Business Administration begin enforcing the 5 percent mark. With the court behind them, experts believe that government contract
    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
    jobs will increase over the next few years for women-owned businesses.

    If the government continues its support of women-owned companies, the number will no doubt co
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    tinue to rise. The latest figures from the Small Business Administration put the number of women business owners at 9.1 million. They have grown twice the national ra
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    te for all private companies from 1997 to 2002, with nearly one-third of them concentrated in health care and social services. These companies employ 27.5 million peo
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ple and contribute an estimated $3.6 trillion to the U.S. economy. But along with the SBA’s slow-footed approach to enforce the 1999 legislation, there are other uni
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    que obstacles women face in the world of business. This underlines the idea that women entrepreneurs shouldn’t treat governmental support as an option, but as a neces
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    sity.

    Women who own businesses are encouraged to be certified as a women’s business and actively pursue not only government contracts, but corporate ones as well. Ot
    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
    er governmental agency support for women includes:

    * National Women’s Business Council, an advisory board that helps define policy related to economic issues of wome
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    n-owned firms;

    * Women-21.gov, an informational site with articles, news and networking opportunities;

    * Office of Women’s Business Ownership, which has an office i
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    n every state offering training, technical assistance and access to federal contracts and international trade opportunities.

    There is also the Center for Women’s Bus
    .

    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
    iness Research, which is funded by the SBA. The organization, which is one of the best sources for information, back up women-owned firms by helping them generate vis
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ibility, seek public and private sector support, and providing the fundamentals for starting a business, including information on taxes, training and securing capital


    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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