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If you’re like me, you love accounting. It’s so fascinating and such an ingenious system. Don’t you just think that Double Entry Accounting is the most beautiful creation of all humankind?

Okay, let’s get real. You probably think

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

accounting is boring and best left to pencil pushing geeks (like me!). I mean…BOOORRRRING! Total Snooze-fest!

Well, my friend, I’m about to introduce you to Real World Accounting for Regular People. But, be careful, it just may ch

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

Examples of combination products may in

nge the way you look at accounting FOREVER! In fact, one of my clients looked up from a spreadsheet one day and said, “Wow, I never knew accounting could be FUN!” You just might have the same experience.

For starters, a lot of peo

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

le think accounting is about math, which is an immediate turnoff. Although accounting does include math, it’s more like a foreign language. All you need to do is learn the parts of that language that actually apply to you. Think ab

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

ut visiting a foreign country. You don’t need to be fluent in the entire language. You just need to know the important things like what to order (or not order) in a restaurant, how to get directions, and how ask where the bathroom

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

Combination pro

s. It’s the same thing with accounting. You need to know what you need to know and the rest is unimportant. I mean, do you really need to know about corporate accounting practices or off shore financial transactions. Probably not.

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

So, how do you figure out what you need to know when you don’t even know where to begin? Follow me and I’ll show you!

The first thing you need to know is this. You must, must, must keep your personal finances and your business fin

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

nces separate. Using your personal checkbook for all your transactions is a bad way to go. Here’s why:

• The Internal Revenue Service wants to know that you have a very clear distinction between your personal affairs and your busi

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

ess affairs. They want details. If you try to pass off personal expenses as business expenses, you’re violating tax laws. They don’t like that.

• If you ever plan to borrow money for your business or get credit from your vendors,

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

our lender or vendor will want to see detailed records of your business performance. Handing them your checkbook register is not going to make them want to give you money or sell to you on credit.

• You need to know how your compa

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

y is performing at all times so you can plan ahead, make adjustments in your operations, and make informed decisions.

• The more accurate your records, the more accurate your tax return. It prevents you from missing deductions.

•

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

Following aspects would a

It’s the only way you’ll know whether your business is making money or if you’re just kidding yourself.

So, if you don’t have a separate checking account for your business, go get one. It’s easy and inexpensive and it will give yo

dd to the challenges in developing combination products:

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

clarity on how your business is really doing.

The next step is your accounting system. Now, when I say “accounting system” I’m talking about an organized way of keeping track of your records. It can be computerized or it can be t

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

e old fashioned pencil and paper route. The important thing is that a) you have one and b) you use it.

Finding a System That Works For You

Your record keeping system needs to be designed so that it works for you. It should be:

•

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

Simple to understand
• Flexible and adaptable to changing needs
• Inexpensive to develop and maintain
• Require little time to maintain
• Be handy and convenient to use

If you use a computerized accounting soft

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

are package like QuickBooks, all those qualifications are met. I generally recommend QuickBooks to my clients because it’s easy to use and you can also find local support for set up and troubleshooting. I don’t whole heartedly reco

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

Professional from academic institutions, pharmaceutical industries, health care indust

mend QuickBooks because I think parent company Intuit is losing touch with its core customer (we, the small business owners of the United States of America). There’s too much nickel and dime-ing and poor support. But, at this point

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

it’s still the most widely used system and certainly meets the needs of most small businesses as far as what it can do.

I do recommend that you get professional help in setting up your accounting system if you don’t have an accou

.

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

ting background. It’s a case of Garbage In Garbage Out. A well set up system will give you the best information with the least trouble. It’s less expensive to have it set up right to begin with than it is to have it cleaned up late

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

Companies that provide selfless information through particip

.

Whatever record keeping solution you choose for your business, the key to success is actually using it on a very regular basis. Otherwise, your business struggles and you’re in constant danger of sliding into the Cash Flow Swamp

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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