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    In my experience, working from home as a mother is a gift. Yes, there are ups and downs, but I wouldn't change a single thing. Everything in life brings challenges;
    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
    it would be a boring existence otherwise! But my belief is that the difference between success and failure is the way you handle those challenges.

    For starters I’
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    m going to tackle the two challenges that stop so many talented and capable mums from starting their own business – fear of failure and low self-confidence. How ma
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    y of you mums reading this are thinking “I’d love to start my own business, but…….. , I don’t know if I can be successful? I don’t have any business experience? I
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    don’t have enough money? I don’t know what to do? I don’t have time? I don’t, I don’t, I don’t.” That’s fear and low self-confidence talking. And how many of yo
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    already running a business feel haunted by these feelings every day? If you do, you’re certainly not alone!

    Before you can truly open yourself up to success you
    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
    need to tackle these feelings by taking control of fear and building self-confidence. So, what’s the answer? Belief! You must believe in yourself. You must beli
    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
    eve that you can build the kind of business you want, with no limitations. Sounds simple doesn’t it, but the reality is that it takes work and discipline. The goo
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    news is that with my series of easy to follow steps, you CAN do it. And when you learn how, success will follow.

    Now’s the time to action, so have a pen and paper
    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
    ready before you read on……

    The First Step – What do you want?!


    Where do you start? Well, whether you’re new to business and don’t have an idea yet, o
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    you run an established business, the following exercise is extremely powerful.

    Ask yourself: What lifestyle do I want, now?


    What do you want your busi
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ness to achieve for you? Take time to think about it, and then write down your perfect life in the present tense, as though you’re already living it now. An exampl
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    e would be: “I own a business that brings me joy and that fits around my family” or “I make ?5,000 per month easily”. Oh by the way, be careful here. Make sure yo
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ’re writing about what you want. Not your partner, parents, children, friends or society as a whole. It’s your business, so you must be the one who is motivated t
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    o make it work.

    Now, whatever you’ve written down, believe you deserve it. You deserve that life. Believe you can have it, because you can. Every morning (or wh
    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
    n you get the chance!) spend a few minutes with your eyes closed and visualise yourself living that lifestyle. Your visualisation can be anything that represents y
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    our goal. See yourself happy, living a successful life the way you want. It may sound a bit ‘out there’, but it works for me and for thousands of others. If you t
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ake it seriously it will work for you too.

    OK, I know I’ve only been able to scratch the surface here. But if you just start by getting clear about what you reall
    .

    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
    want from your business and visualise it, you’ll have made a huge step. Only by knowing what you want, can you begin to believe and achieve. Only by believing wi
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ll fear begin to dissipate and your confidence begin to grow.

    And remember, there is nothing you can’t learn, and nothing that can hold you back, unless you let it


    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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