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Does your business qualify for a government contract? Many business owners avoid government contracting for a number of reasons including, but not limited to, excessive documentat

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

ion, stringent financial reviews and the general complexities associated with federal and state contracts. As a result, many business owners (about 80% of the nations small busin

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

Examples of combination products may in

esses) do not participate in this trillion dollar industry.

Anybody who has ever attempted to investigate government contracting at the federal level is keenly aware of the myriad

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

details and bureaucratic nightmare and the volume of information that must be absorbed before an individual can even begin to make sense of how the system works. Frankly, it is b

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

izarre. The people who work for the governments (local, state and federal) simply have too much time on their hands to develop rules, regulations, policies and procedures and a do

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

Combination pro

cument for everything. Who has the time or inclination to muddle through all this complexity to bid on a highly competitive contracting process, which you will probably not win an

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

yway? That’s a good question and here are some answers.

Getting a government contract, while highly competitive, will probably not create a windfall stream of revenue for your bus

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

iness but it will produce a steady stream which you can be assured of timely payment and, this revenue can be directly applied to cover your overhead. This will allow you to achiev

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

e economies of scale that will enable you to win more profitable commercial contracts in the private sector. It also adds market credibility with your customers when they know you

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

are substantial enough to service a government contract whether it is a local, state or federal contract.

Most people think of the fed when they think of government contracting.

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

But there are many purchases made by local and state governments, which your small business may be very well qualified to compete. Your local government purchases many things not

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

Following aspects would a

normally considered: everything from bathroom supplies to car leases, audiovisual equipment and janitorial services. The local government should be your first target for winning

dd to the challenges in developing combination products:

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

a contract less than $25,000.00

And that is the key to success: One thing the various levels of government look for is a track record with commercial customers. They want to know

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

that they are contracting with a business that can indeed deliver the contracted goods and services. And the best way you can gain credibility with the government is to start sma

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

ll and build a track record. How? Sell to townships and small cities or county governments within your state and be successful at servicing your customers well with emphasis on c

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

ustomer service. Their testimonials will carry a lot of weight with each successive small government you bid to contract with. You build this reputation layer by layer from the gr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ound up. You can’t get the big things done until you get the little things done first right? So start small and contact your county to find out how the bidding process works in y

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

our area.

If you would like more information on this topic, visit our site and check out the Government Link section for high quality links related to government contracting. Our

.

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

links are highly qualified targets that will show you where to go within the federal and state governments.

This article is one of a three (3) part mini series of articles relate

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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Are you prepared in the event of a sudden job loss? Do you realize your own potential and value? Individuals need to know how to market their skills just as businesses need to know how to market their goods and services? Read what you can do to be in control if your world is shaken by a job loss.

You cannot fix a bad computer with another bad one. The viruses residing in each of the partner will spread to one another causing both to be ruined

Whether you write a personal check, use the equity in your home, use your 401K money or get a commercial loan, one way or the other, you're financing your franchise. Financing it the right way is critical to your long term success. It might not be as critical as finding the right locations, but it's close.

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