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    The foundation for success…

    A common challenge for all businesses is how to pay for the equipment needed to perform their services. Even among experts and professionals, opinions will often vary.
    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
    The one thing you must recognize is that each business is unique and there are no standards that work for everyone. Only you know what your capital reserves are and what type of reserves your bu
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    iness will require from month-to-month. While some businesses are more sophisticated than others, only you have access to the full spectrum of your financial position today and the forecast of wha
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    t responsibilities there are to come. It is not only essential that you prepare yourself adequately; it’s crucial.

    In the beginning, one of the first professionals you should confer with is a Tax
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    professional. This person can view your company in its totality and then match your company’s needs with the proper tax plan. It is an accepted belief that proper tax planning is the primary step
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    to a successful business. Upon properly identifying your needs, it’s now time to strategize your method of operation. To assist you with that method, we’ve compiled a simple list of the advantag
    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
    s and disadvantages of leasing equipment versus that of buying it. This list is generic but reveals the industry norms of features and benefits. As you review, apply these characters to your busi
    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
    ness and see how it measures up. Good luck!

    Own
    1. When you decide what equipment to use, you are of course purchasing it. The equipment is yours to do with as you please.
    2. By purcha
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ing the equipment, you have immediately created an asset to your company profile.
    3. Depending on what your equipment is and how your company is structured; you may be entitled to certain tax
    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
    benefits such as writing off the expense in the first year. (Check with a tax professional)
    4. There are no payments. (You own it.)
    5. Now that you own the equipment, you have the option
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    to resell it. (At a lesser price)

    Lease
    1. The first benefit is that if you don’t have the reserves to purchase, a lease is a viable option.
    2. If you were going to purchase with a bank
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    oan, then the bank would likely require a 20% down payment. By leasing the equipment, the standard is that you are required one or two month’s payment upfront and that’s it.
    3. Although you a
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    re leasing the equipment, it is still an asset to your company. 4. Even though you have a monthly payment, you also have the option to upgrade the equipment prior to it becoming obsolete.
    5.
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    hen you acquire assets, you want assets that will appreciate in value not depreciate. With many equipment materials needed to function, they will depreciate after the first year of usage.
    6.
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    By leasing all of your equipment, you may be able to fully write-off up to 100% of your payments as a business expense. (Check with a tax professional.)
    7. Most items can be leased such as pho
    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
    es, furniture and computers, not just heavy machinery.
    8. Choosing a lease allows you the flexibility to maintain capital reserves for payroll and miscellaneous expenses that may occur.
    9
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    . There are numerous types of leases that can cater to your business profile and your company’s needs.
    10. Lease rates are ‘fixed’ and range in term from 12 to 60 months.

    As you can see, the
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    eatures of leasing far outweigh that of purchasing or owning the equipment for many businesses. Eight out of ten businesses prefer leasing over that of buying. The list you just reviewed points o
    .

    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
    ut the key components to both options but with further investigation, you’ll find that leasing offers many more opportunities to fulfill your desires.

    Please speak with an equipment leasing profes
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ional to locate the proper lease for your company. It’s good business!

    J. R. Parler

    Commercial Real Estate and Finance Consultation
    JRParler@yahoo.com


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