Main Subject - Business

This is not a course in how to get rich by embezzling funds from the company your work for but a group of suggestions on how to protect your company from this heinous crime.

Embezzlem

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

ent is defined as theft of money or property from a business by someone who has custody of the funds or property. Often embezzlers are the people you would least suspect. After all y

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

Examples of combination products may in

ou wouldn’t put your money into the hands of someone you didn’t trust now would you? So don’t get fooled by an innocent looking face. Of course not everyone you meet who comes across

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

as trustworthy is a crook in disguise. But by putting into place a few simple procedures you can protect your company.

First of all whether you are just starting in your business or

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

been in business for awhile, educate yourself in the basics of bookkeeping. You should be familiar with the terms used and their definitions as well as the proper flow of paperwork.

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

Combination pro

Secondly know how to read your financial statements. Understanding the types of accounts and how they increase or decrease as transactions are posted will help you see when things ju

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

st don’t look right – a possible sign that someone is dipping into your funds for their own benefit. You should at the very least have a realistic “guesstimate” of how much you are sp

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

nding for the different expenses your company incurs. If you are seeing higher than expected expenses on your financial statements, than you might have a problem that needs to be inve

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

stigated. If you do not review your Balance Sheet and Income Statement each and every month you might miss these important clues.

Review your bank statements every month checking for

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

checks or charges that do not make sense to you. If you are making deposits made up of cash and not preparing and making the deposits yourself (which I highly recommend) than also ve

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

rify the deposits recorded on your bank statement. I know you might leave the actual reconciliations to your bookkeeper but you should give the statements a once over yourself. You w

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

Following aspects would a

ill also want to check the dates, amounts and signature on all the checks because the automated systems the banks now use do not always catch unsigned checks, old dates and mismatched

dd to the challenges in developing combination products:

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

amounts.

Only you should have the responsibility of signing checks. If you are signing all the checks you will have the opportunity to spot errors and possibly outright thefts.

Comp

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

any credit cards should be used judiciously and statements should be checked by you when they arrive each month. If you cannot identify a charge then investigate it with the company h

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

lding the card. Often the problem is cleared up quickly and you realize after talking with them it is a legitimate charge. But better safe than sorry.

Payroll checks can be especial

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

ly problematic even when processed by an outside payroll service. After all, who is calling in the payroll? Not you the business owner I bet. Check out your payroll reports before

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

Professional from academic institutions, pharmaceutical industries, health care indust

the checks are given out. Know your employees pay rates. Verify that vacation, sick and other paid days off are correctly handled.

Only on your authority should an employee expense

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

reimbursement or loan be issued. Make this a hard and fast rule.

There are many, many hard working and very honest bookkeepers but a few have unfortunately given these good people a

.

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

black eye. By being vigilant you are not only protecting your company but you are verifying that the bookkeeper you employ is in fact the trustworthy person you already believe them t

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

Companies that provide selfless information through particip

o be – and for all you great bookkeepers this is protection for you as well. You cannot be accused of misuse of funds if you don’t sign checks, use credit cards and authorize payments

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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