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Let’s face it, running a janitorial company is not easy. It’s not glamorous. And, at time’s, it’s not very profitable. But, when you add the ever lingering possibility of lawsuits by

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

your employees and customers and worker compensation claims, you begin to see why a lot of company’s don’t make it past their 3rd year!

Look in your local yellow pages, and you’ll disco

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

Examples of combination products may in

ver an unending line of lawyers, all waiting to file a claim against someone, anyone, for just about any reason imaginable.

If you’re a small company, you may be dependant on your custo

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

mers paying you on time, so that you can meet your payroll cost. That’s too bad. Why? Because, many business owners are habitually LATE on their Account Payables. And, this means tha

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

t you have to borrow the money to pay your employees and of course, pay it back with interest OR you have to tell your employees that payroll will be a few days late, and risk them quitt

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

Combination pro

ng or worse, going to the Labor Board.

Now, consider the cost of dealing with Workers Compensation claims. Even if the claims are true, you have to stop running your business (sales, m

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

anagement, supervision, etc.) and fill out papers, possibly meet with their attorney, and a hundred other task related to the case.

But, what if it’s a false claim (your employees would

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

n’t file a bogus claim against you, would they?)

Now, you have to hire your own attorney, and gather witnesses, and drudge up documentation supporting your case PLUS stop running your b

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

usiness, filling out forms and meeting with the plaintiffs attorneys, etc.

What’s at risk? For starters, your time, and lots of it. And, thousands of dollars in attorney’s fees and da

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

mages. And, quite possibly your personal assets (if you’re not incorporated).

There are a couple of ways to protect yourself.

The first way is to clean all of your buildings yourself.

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

That’s right. Every square inch of buildings that you currently have…. Clean them yourself. After all, you’re not going to file a claim against yourself, right? If you did, YOU would

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

Following aspects would a

have to pay YOU!

Of course, you wouldn’t be able to take on any new business, if you couldn’t find the time to clean it yourself. This would basically create a ‘glass ceiling’ on your

dd to the challenges in developing combination products:

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

income, and lock you into being an employee for as long as your company continued to operate.

If this doesn’t sound like the way to go, you’re right… it isn’t. A more feasible alterna

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

tive is to merge with another company, and allow them to bill your customers, train your employees, and deal with the headaches of running a janitorial company.

This would free up your

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

time to do more selling, quality control, etc. Furthermore, you would have more time for your family and friends, social activities or anything else you’d like to do. But, most importa

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

tly, you would transfer all liability to the other company, thus protecting your company’s name, assets and reputation.

In return, you would pay them a small percentage of the business

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

Professional from academic institutions, pharmaceutical industries, health care indust

that they’re managing for you. The percentage would have to be negotiated in advance, but expect to pay around 10-15% of your gross billing. But, when you factor in the protection from

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

liability AND the freedom of time that you receive in return, 10% is a steal.

It’s better than hiring an employee to do it for you. After all, if you hire an employee and your company

.

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

is sued, YOU (the business owner) are still at risk.

For more information on how to find and select a company to merger with, visitelopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

es.html " TARGET="_new"> http://www.breakthecycleokc.com/Opportunities.html .

D. Brownlee http://www.BreakTheCycleOKC.com

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 - Janitorial Liability: Protecting The Owner Of A Cleaning Company

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