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When the exact longitude and latitude of the ship are known it's possible for the captain to chart an accurate course across rough seas. The g

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

eneral manager of a business is like a ship's captain. Knowing your location and direction is fundamental for charting the right course in sai

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

Examples of combination products may in

ing and in business.

The charts for a business are its income statement and balance sheet. A good general manager uses these to know exactly

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

where the business is and where it is headed. Armed with this information, better business decisions are more likely. A competent bookkeeper p

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

ovides these reports accurately and in a timely fashion.

It is the job of the bookkeeper to accurately state the condition of the business in

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

Combination pro

a real time basis. The bookkeeper records all changes in the financials of a business using a double entry accounting system based on the fac

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

that Assets = Liabilities + Owner Equity. All business transactions are accounted for using this system.

Some basic tools of the bookkeeper

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

are:

Ledgers such as accounts receivable, accounts payable, fixed assets

Journals for recording each financial transacti

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

Vouchers such as checks and numbered bills for services or material

Invoices representing sales of products or service

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

Journal entries (recurring and special)

Trial Balances for interim reporting

Financial Statements beginning

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

with the income statement and balance sheet Four important features of competent bookkeeping are:

Timeliness:

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

Following aspects would a

It's generally important to record transactions on a timely basis. This means that invoices and bills are posted by the next business day. How

dd to the challenges in developing combination products:

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

ever, on some instances similar transactions are processed in batches.

Account Reconciliations: It's also critically import

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

nt for accounts to be reconciled monthly to assure accuracy. For the cash to be right, for example, check books must be reconciled to the bank

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

statements and outstanding checks must be identified.

Analyzing Accounts: For payables and receivables, it's important to k

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

ow the age of the bills and invoices. How much is “current” and “overdue” is basic to staying on top of your credit rating and vendor relation

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

Professional from academic institutions, pharmaceutical industries, health care indust

s. For receivables it's important to know how you are doing in collecting funds from each of your customers.

Matching: Reve

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

ues in a fiscal period must be matched to expenses incurred in that same period. When items don't match in the same period, inaccurate income

.

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

statements are the result. This leads the general manger to miscalculate the direction of the business.
Good bookkeeping is t

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

Companies that provide selfless information through particip

e foundation of good accounting. It is also fundamental to help the general manager steer the business through rough seas and into calm waters

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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In our careers and lives there are times when one thing after another seems to overwhelm us and bring us down. That’s when we are challenged to concentrate on the task at hand, to focus on the one thing that will help us accomplish the one job that needs to be completed in order to take care of the higher goal on down the line.

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