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Each business has its own unique needs and concerns when it shops for property to serve its business needs. Each business owner is concerned with whether to lease or buy, how much space is needed, what kind of property is needed, how much to pay for the purchase or l

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

ease, how to negotiate the best price, how to negotiate the best terms, and how to find the best location. The following six points need to be considered before leasing or buying business property:

1. Lease or Buy:
It is usually better in the long-run to

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

Examples of combination products may in

own your business property. However, that may not be the case if you are short on cash. It may be a better decision to lease a facility when you are just starting out. When you lease a building, your cash outlay is much less than it would be if you purchase a build

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ng. The purchase will require a substantial down payment, and you may have a more important use for you cash when you are starting your business.

2. Find the Right Location
You must consider how long you will be in the same location. If you think you w

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ill be in the same location for one or two years, the location only has to serve your purposes for that length of time. If you intend to stay longer in the same location, you must be satisfied that the location will be adequate for a longer period of time. For examp

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

Combination pro

e, will there be sufficient parking as your business grows? Is it possible that area will become a high crime area? Could you lose your space by eminent domain for street expansion? Are there neighboring businesses that could have a negative impact on your business

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

? Will the space continue to be convenient for your customers, employees, and vendors?

3. Have an Attorney Review Lease or Purchase Contract
Do not blindly sign a lease or purchase contract until you have an attorney review it on your behalf and try to n

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

egotiate for a better price or better terms. The property owner will probably have the lease or purchase contract drafted by their attorney, and it will be written to favor the property owner. Do not hesitate to review and negotiate the document and have your attor

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ey do the same.

4. Negotiate the Best Deal for Your Company
The results of good negotiation may save your company enough money to hire more employees, to launch a marketing campaign, or to update your equipment. You need to negotiate the best terms suc

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

h as the term of the lease, renewal options, rent increases, a lower down payment, acquiring additional space in the future, etc.

If you negotiate a lease, you need to know how the tenant's share of expenses is calculated. Is it based on total square footage of the

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

uilding or the square footage leased by the landlord? If you will pay a portion of the common area expenses or taxes, your landlord must provide a detailed list of expenses prepared by a CPA. You should also have the right to audit the landlord's books or records.

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

5. Choose the Right Amount of Space for Your Business
Whether you are just starting your business or you need more space to expand, you want to choose the optimum amount of space. If you underestimate your needs, you will have to relocate and that can b

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

e expensive. If you overestimate, you will pay for unproductive space. You need to be sure that you know the usable square footage of the premises

In deciding how much space you need, think about how many employees will be physically located in your new facility.

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

o you anticipate that any of them will telecommute and work from home? What are your projections for the employees you will need in the next two years?

6. Building Features and Layout
What do you really need in your facility? Consider the cost of each fe

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ature to see what is financially feasible. What office design will best accommodate your employees, customers, and vendors? What design encourages the most efficient production? You can research office layout and design on the internet and at the library, or you ca

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 hire a professional designer.

Your business premises must be able to operate during the regular business hours without interruption. Your customers, employees, and vendors must have easy access and sufficient parking. The business premises should be thoroughly in

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

pected so that you will not incur substantial repair expenses after you take possession.

Whether you lease or buy, these issues must be considered carefully to protect the interest of your business. Before you sign any documents, research the property, the neighborh

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ood, and the area around it. You need to know as much as possible about any property where your business will be located.

Jo Ann Joy, Esq., MBA, CEO
The future of your business starts here!

You may contact Jo Ann by phone at (602) 663-7007

.

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

by fax at (602) 324-7582, by email at joannjoy@Indigo Business Solutions.net, and by mail at 2313 East Ocotillo Rd., Phoenix, AZ 85016. Copies of any articles will be provided free of charge.

For information about other important legal, tax, and business top

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

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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Digg It - Six Things to Consider Before You Buy or Lease Business Property

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