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    “Sixty thousand dollars? You guys are joking right?” I had just completed my first ye
    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
    ar of being fairly successful on the internet. My taxes had been submitted to the acc
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ountant. I was on the verge of greatness. Then I got that bill. Sixty big ones. “How
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    did this happen to me? Where am I going to get the money for that?” These thoughts ra
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    through my head for a couple of days before I regained control. I decided not to foc
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    us on the negative. Instead of wallowing in misery I vowed to help others not repeat
    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
    the same mistake

    So how does it happen? Very simple. You have a breakthrough year. B
    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
    reakthroughs have a tendency to happen without notice and become an avalanche of cash
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    That is the good part. The bad part is that most people are so used to scraping by t
    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
    hat they are unprepared for their new found wealth. The end of the year approaches an
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    d BAM the tax bill makes them pass out.

    Here are things you should talk to your acco
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    untant about. Incorporation. First and foremost. My wife and I only had a DBA and a b
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    siness account and we ended up paying $60,000 instead of $30,000. That’s right; doubl
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    e the taxes for not being incorporated. Keep track of receipts when you eat out and A
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    LWAYS write the name of the waiter on the top. If you leave a card for the waiter you
    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
    can usually write off the lunch but you MUST write the name of the waiter on your re
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    eipt to keep good records.

    Use one credit card and bank account for business and one
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    for personal. When you mix these two up it can be a records nightmare at the end of
    .

    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
    the year. Deductions will get lost. There are many more things you should look out fo
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    r but these are the ones we messed up. Talk to a good accountant for the right advice


    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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