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The title indicates the most important words in real estate. As I have just found out, it is very important in business also.

You would think that a company that does all its business on the Internet

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

could be located anywhere. To some extent that is true. However, it should, at the very least, be located in the country where you live.

Heaven help the unwary. I listened to a New York lawyer and I

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

Examples of combination products may in

’ve been paying and paying since.

My home is in Canada. I contracted with a New York firm to have them build me a web site and to provide coaching. It worked well. I then talked to a New York lawyer

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

bout setting up a company with my wife and I as partners. He suggested that because the United States law favors companies, that the business should be registered in the United States. At the time, it

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

seemed like a good idea to me too.

I contracted with a tax firm to do my accounting and tax preparation and a service company to do the registration and set up of my new business. So far, so good, a

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

Combination pro

though by now the fees for everything had cost me nearly $10,000 Canadian. Ongoing monthly fees for hosting my web site, maintaining a United States mailing address, tax consultation and web site main

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

tenance run about $150 Canadian.

Then the problems started. I couldn’t open a business bank account in Canada because my company was in the United States. I couldn’t open a business account in Nevada

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

where my company is registered, because I had to physically be there to do so. This is a requirement of the Patriot Act. I live north of the 54th parallel, over 12 hours north of the border between t

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

he United States and Canada.

I contacted PayPal to ascertain if I could use them to collect payments for any products I sold. PayPal requires a United States bank account for a United States company.

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

Back to square one.

During all of this mess regarding bank accounts, my 93 year old father died. I will be driving over 2000 Kilometers to Vancouver Island to attend the memorial service.

On the way

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

back, I thought that I could cross the border south of Vancouver, British Columbia and open an account at a bank in Blaine, Washington. I phoned Bank of America to see what documentation I would need

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

Following aspects would a

to bring with me to open a business bank account for my Nevada company. After being put on hold numerous times and transferred from one person to another, I gave a young gentleman my telephone number

dd to the challenges in developing combination products:

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

and asked him to have someone from the small business department in the Blaine branch to call me.

About two hours later, a very nice young lady called and I explained my problem to her. She said that

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

Washington State treated companies from other states as foreign businesses. This meant that I would have to contact the State House and get them to provide me with a form to transfer my company from

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

evada to Washington State where it would be re-registered as a Washington State business. Sorry! Not going to happen. Back to square one. No business bank account.

I examined a road atlas of the Unit

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

ed States and Canada. To drive from Vancouver, BC to Mesquite, NV and back to Calgary, AB, where I had some business to take care of, would take a week. (2541 miles - 4065 Km). At an estimated cost of

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

Professional from academic institutions, pharmaceutical industries, health care indust

$4.50 Canadian per gallon of gas, the cost of gas alone would be nearly $500 Canadian. Add in meals, accommodation and an oil change for my GMC Jimmy, and the bill would work out to about $1500 Canadi

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

an for just that part of the trip. A bit expensive for the price of opening a bank account.

I’m sure I’ll come up with a solution to my problem. What I’d like to do though is to ensure that no one el

.

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

e runs into the same problems that I did.

To avoid them, make sure that you register your business in the state or province in which you live. In this way, you will have little trouble getting a busi

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

Companies that provide selfless information through particip

ness bank account. You can also pick lawyers, accountants and tax advisers from firms that you are more familiar with. And make sure you avoid New York lawyers, unless, of course, you live in New York

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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Many Americans are willing to work overtime for free. On average, Americans are willing to work an entire extra day of overtime a week. What happens when all that extra work doesn't pay off with job security or promotions? At least with your own art workshop center, you are securing your own future.

If you are starting a medical billing software company, you want to be very careful when hiring a support person. Some very special skills are required. What follows are some of the main ones.

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