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  • Advice You - Rejuvenate & Re-Fuel Your Inner Drive

    I believe that as solo-entrepreneurs, business owners, and executives we all need a pat on the back. Give yourself commendation. Why? Because we have the courage to step outside of the corporate box and start our own businesses, be our own bos
    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
    s and take on the challenge and responsibilities required for this adventure. In order to even contemplate that step we must have had a vision, a dream and a passion to bring it to fruition. So commend yourself.

    Now, we’re in business. We’ve
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    een working our little brains out. We are dedicated to making our dream come true. But some time has passed and we may have exhausted ourselves of ideas, that passion that once used to drive us is fading and our never ending “to do list” is ov
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    rshadowing our dreams.

    Do not be discouraged, we only need to refuel. Picture the never ending stair master at the gym. I know we all dread that machine, because it seems like you just keep climbing and there is no landing. But each step is a
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    further progression. Each step brings us to a higher level. Perhaps by reading these strategies we can replenish our passion and reinvigorate our inner drive. So let’s focus on a few ideas that I have found to be helpful.

    1) Narrow Your Ni
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    he I know that as a woman, mother, wife, housekeeper, and a chef, solo-entrepreneur and so on, I tend to think that I can handle it all. Maybe not with grace, but I can accomplish a lot. I am a multi-tasker. We assume that if we can do so
    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
    in our personal lives, the same should be true in our professional lives. No doubt, we can manage a lot. And as solo-entrepreneurs there are a lot of hats to wear. Business owners are in advertising, marketing, accounting, and so on. But when
    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
    it comes to the services we offer we should consider “narrowing our niche”.

    We may be more proficient in a particular area of our practice. By honing in on our skills in that area, we are creating a competitive edge, an area of expertise. You
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    can position yourself as a leader in your own industry. Opposed to fitting in with a thousand of professionals offering the same service, we are now exposed to clientele as specializing in a certain skill. We can also appeal more specifically
    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
    o a “target market”.

    2) Partnerships and Alliances Wouldn’t you agree that we all need support? We need confirmation that we are heading in the right direction, a resource for assistance, or an honest opinion when we need advice. That
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    s why it is essential to group ourselves together with a variety of individuals who are enlisted within a similar profession. It also increases our professional appearance to clients when we can refer them to an associate of ours who specializ
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    s in a particular area of expertise. (Hence the importance of “narrowing your niche”). There are many associations and links available to aid us in our endeavors. So make the connections needed and integrate yourself with a partner or an allia
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ce and unite together with a support system. (E.g. become more involved with the community at www.solo-e.com/community/ where you will connect with individuals who are coming together to help you present yourself with the resources you need).
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin

    3) Maintaining Passion The word passion is described as: “enthusiasm, excitement, desire for a particular activity, or devotion to a cause”. How do we maintain that enthusiastic approach? Focus on your core message. This is the innerm
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ost substance of your business. Maybe our business is a consulting firm. Why not focus on and think about how you are empowering other others to accomplish all that is needed of them by assisting them with your services and/or your products.

    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
    ry focusing on the message that you are communicating to others and try to incorporate that in your everyday duties. For instance, the core message of my company is growth. Not only personal growth, but business growth and helping other busine
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ses grow, expand, and develop. I try to allow clients to see the quality of my concern and I enjoy the opportunity I have to help them. When they become more productive and increase profits, I benefit too! My motto is “If you grow – I grow!”

    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    nother way to maintain your passion is to find similarities in your personal values and your business. All of us have a certain moral code. We all have things that are of particular importance to us and if we harmonize that connection between
    .

    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
    ur work ethic and our personal ethics we will be passionate about what we do. Most of us appreciate sincerity from our family, friends and associates; by reflecting the same sincerity to others we are highlighting its importance to us. Having
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ynchronization with our personal and business values will bring about passion, thus helping us to enjoy the entrepreneurial experience.

    From my business to yours, I wish you much success and delight in your journey.

    Copyright, 2004, Amy Ewar


    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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