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  • Top Adding - Was It A Knock At The Door?

    Your success is so much dependent upon your ability to recognize opportunities around you. You know it, if you fail to do so, you would only lose business. I get so many mails asking me ques
    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
    tions that fall in this very category – how to look for an opportunity or how to recognize one when it is right there before your own eyes!

    Opportunity doesn’t come with a loud bang or some
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    kind of lightning in the sky! It would come creeping to you one fine afternoon, totally unannounced and you wouldn’t even know of its presence. Soon it would be gone to some one more alert
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    and receptive. Sounds too philosophical? Well I can’t sound more pragmatic than this. Just carry out a retrospective analysis of different situations that you handled or failed to handle
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    r even failed to perceive that they existed. For example, how many times did it happen that you met someone for the first time and didn’t even care to leave your business card with him or he
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    or that there was a chance to attend a convention or a seminar and you absented yourself? Well, in my opinion, these were golden opportunities that you failed to recognize. I am sure, 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
    can make a good list of such instances when the opportunity knocked your door and you didn’t even care to let it in!

    Failure to recognize the opportunity happens when we have not evolved
    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
    ourselves to that level. It’s being like a child who cannot obviously understand things beyond its age. Unless we work towards the achievements, we will never be able to reach that maturity
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    level to discern different business situations. A smart entrepreneur, merely by talking to a person, can figure out the possible merits or demerits of doing business with him or her. With
    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
    is continuous efforts to make the best use of every instance, he develops a clear understanding of what is an opportunity and what is not.

    I can only advise you to have a good look around.
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    herever you are, whatever circumstances you are in, you will find enough profitable situations, only you have to recognize them. I remember this case study about a Marketing Manager of a J
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    apanese noodles company, who around 25 years ago went to study the market potential of noodles as a product in India. He, along with his team, carried out an extensive survey in a particul
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    r region in India by talking to people about their eating habits. To his dismay, his extensive research concluded that the inhabitants of that region preferred only their staple food and dis
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    liked anything other than that. The frustrated Marketing Manager called up his CEO in Japan and said, “Boss, sorry to disappoint you, but I think we’ll have to dump the whole idea of launc
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ing our product in India. People just don’t like foreign food here!”

    To that the CEO said, “Wow! We have a golden opportunity there! If people in that part of the world, don’t even know wha
    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
    noodles are, we would be the first ones to tell them!” The Manager thought probably his boss had gone berserk, but little did he realize, noodles was going to bring a revolution in the eat
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ing habits of millions of Indians with a slew of foreign companies starting their operations one after the other. Today noodles are a part of the Indian food and families have accepted thi
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    once-a-foreign-food as an integral part of their daily grub.

    Well, the CEO surely had an evolved thinking! He was so shrewdly able to recognize the huge opportunity, he opened a whole new
    .

    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
    vista for more foreign companies that established their seemingly unacceptable products in India over the years.

    It’s the way you look at it. What seems like a mere situation to you could
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    actually be an extraordinary chance for another person. But if you are evolved in your perception, I am sure you would not fail to welcome any advantageous business situation you come across


    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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