Just Other Articles

I had spent several weeks working with my client getting their books in order and we were now finally able to review a pretty decent

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

Balance Sheet. By that I mean one that was accurate, not necessarily pleasant to look at with tons of money lounging around in the a

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

Examples of combination products may in

sset area. I spent a few minutes reviewing with my client what each of the areas were representing, liabilities, assets, equity, etc.

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

, when I saw a confused look on the business owner's face. "What's the matter?" I asked. "Well", he said, "I don't understand why th

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

e Balance Sheet shows that I am making pretty good money, but I don't seem to be taking any of it home."

So we printed a copy of his

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

Combination pro

Profit & Loss Statement for the year and began to review it as well. Again, this document was an eye opener for my client, a docume

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

nt that was not available prior to this time because of all of the inaccuracies in their book keeping system.

As we began to go over

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

the details I commented to him that one of the biggest culprits causing money to disappear was not controlling expenses. "But we do

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

n't spend money on things we don't need." he said. "As you can see, we buy equipment for resale, pay our employees, buy needed offic

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

e supplies, pay our accountant, attorney, and of course you, but we don't spend money on unnecessary things. So why don't I have mor

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

in the bank?"

"Are you sure that you only spend money on necessary things?" I replied. "Have you filed your taxes for the year yet

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

Following aspects would a

?" "Not yet." he said, "We had to file an extension because we were not ready." "Oh" I said, "An unnecessary expense because your b

dd to the challenges in developing combination products:

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

ooks were shabby, and how about your payroll taxes? Looks like those were paid a little late last year as well." "Yes" he said shee

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

pishly, "Another unnecessary expense, I guess."

I went on to explain to my client that controlling expense means more than just the

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

obvious areas of the business, because it is the hidden, extra expenses, that erode your profits. Keeping your books in order is ess

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

ential to controlling these types of costs.

Running a business is not easy, if it were, everyone would be doing it successfully.

Wh

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

Professional from academic institutions, pharmaceutical industries, health care indust

en I was going through basic training in the military (A while back!) we were made to polish our soap after each shower. I thought i

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

t was pretty stupid at the time, but in retrospect, I understand the symbolism of that task. Don't allow the things you use daily (f

.

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

inancials, client records, invoices, etc.) to become unattractive and in disarray. Showering with a clean bar of soap will not only

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

Companies that provide selfless information through particip

make you feel better but will demonstrate that you are a stickler for details, an essential ingredient for success.

To Your Success

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.justotherarticles.org.ua/article/40710/justotherarticles-Where-Has-All-My-Money-Gone.html">Where Has All My Money Gone?</a>

BB link (for phorums):
[url=http://www.justotherarticles.org.ua/article/40710/justotherarticles-Where-Has-All-My-Money-Gone.html]Where Has All My Money Gone?[/url]

If you are looking for a job, you need to know how to negotiate salary. This article will show you how to effectively negotiate a higher salary to protect your best interests and come out on the winning end!

After doing your research, you decide that advertising in a specialty, free, local magazine or newspaper is better than other forms of media (billboards, radio, TV, newspapers, etc.). Now, which one do you choose? The answer – the one that will give you the best exposure for the dollar!

You say you're ready to advertise. Understanding the benefits and pitfalls of these different forms of media will help you get the most out of your advertising budget.

Tags

Links

Just Other Articles - Where Has All My Money Gone?

Related Articles: