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It is a well-known fact that as your business becomes larger and more succes

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

sful you will probably have to hire some type of extra help in dealing with

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

Examples of combination products may in

financial calculations and bookkeeping. The larger you company becomes, howe

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

ver, the higher your accounting costs are likely to be, often making the nee

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

d to pay for financial services a frustrating drain on your profits.

There

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

Combination pro

are ways to minimize these expenses, however, by increasing the efficiency o

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

f your company’s financial infrastructure.

Since most accountants charge by

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 hour, your primary goal should be to make the work as easy (and non-tim

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

e consuming) as possible for your accountant. One of the easiest ways to do

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

this is to ensure that all records are stored in a manageable and orderly fa

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

shion. This usually means getting in the habit of storing your monetary figu

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

Following aspects would a

res on a computer, often in the form of a spreadsheet, chart, or other easil

dd to the challenges in developing combination products:

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

y accessible document.

When entering figures into your computer it is often

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

a good idea to get the simple calculations out of the way yourself before a

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

n accountant comes in. After all, it doesn’t make sense to pay someone else

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

a high hourly rate to do something that you could very easily do all by your

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

Professional from academic institutions, pharmaceutical industries, health care indust

self.

Finally, when it does come time to hire help, you should compare offe

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

rs from a number of accounting firms before making a choice. It might also b

.

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 a good idea to hire temp bookkeepers for the more routine record keeping w

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

Companies that provide selfless information through particip

ork, as they will generally charge you a lot less than a fully-qualified CPA

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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I also provide the client with the alternatives to Reverse Merger, such as Regulation D Offering, Direct Public Offering and private placement.

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