Advice You - Business

New small businesses must make many decisions. One of those is to decide how to handle the accounting and bookkeeping chores. Here are a few

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 related questions all new businesses need to consider.

Which Type of Accounting Help is Best for New Businesses?

New busi

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

Examples of combination products may in

nesses need an expert, not a clerk.

Accurate numbers are crucial to the success of any new business venture. An expert can provide those num

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

bers - a clerk cannot. Yet many new small businesses skimp on the accounting side of their business by either hiring a clerk, or by trying to

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

handle the accounting alone. Is it any wonder that so many new small businesses fail? Starting a business is like taking off in a plane. You

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

Combination pro

want an expert in the cockpit to help get that plane off the ground! Once it’s in the air and flying, then you can safely let somebody else p

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

ilot the plane for a while.

Similarly, new small businesses need somebody fully trained in the accounting software, accounting principles, a

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

nd financial reporting. This will help ensure a smooth take-off for the business by providing the financial reporting, so management can make

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

informed business decisions.

Are there Immediate and Tangible Advantages to Outsourcing?

Yes, outsourcing has several tangible and

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

immediate advantages over hiring in-house:

1. Get immediate and expert help for the accounting tasks - no training necessary.
2. Higher

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

level of experience = less time the manager spends overseeing the accounting tasks.
3. No potential entanglements of an employee/employe

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

Following aspects would a

r relationship.
4. Save in payroll related expenses and hassle. Why deal with any of these if you don't have to? FICA payments and repor

dd to the challenges in developing combination products:

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

ting; Federal Withholding payments and reporting; FUTA payments and reporting; state tax payments and reporting; work comp payments and repor

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

ting. None of these apply to outsourced help; all apply to in-house help.

Which is Less Expensive - Outsourcing or Hiring In-House?
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
b>

The actual cash going out the door will probably be about the same.

For about the price of a full time clerk, the new business can buy a
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
part time expert. Remember that there are payroll related expenses associated with hiring in-house; be sure to factor these into your decisio
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
n when comparing salaries/wages.

Also, remember that the part time expert does not need to be trained or managed closely. This means that
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
the new business saves money there too, because the part time expert is not a not a drain on management's time. This is a very tangible
.

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
consideration that should be remembered.

Final Thoughts

New small businesses need immediate and expert help in the initial stages, a
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
nd should spend their money wisely by hiring the best help they can afford. Get that plane off the ground quickly by hiring an expert to help

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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Advice You - Outsourced Accounting for New Businesses - Save Valuable Resources through Outsourcing

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