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If you are in business, then guess what - you are either an accountant by default or you need to hire one. Why? People ask that question while letting the year roll by until taxes come due. Oh no!

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

Why do I have penalties?

Simple, you are not an accountant and you should have hired on. So the first rule of business accounting is to hire one if you are not one. Second rule of business accou

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

Examples of combination products may in

ting is to hire an accountant to review your accounting before filing taxes.

Most individuals starting a business are unaware that the f

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

ling deadlines for corporations and small businesses are different from personal filings. While personal income tax returns are due in April. Corporate and business tax returns are due in March. H

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

s often leads to many late fees and so forth associated with late filing penalties.

Keeping good records is another concern for most new business owners starting out. Many new business owners do

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

Combination pro

ot understand the tax code and do not understand what can be written off as an expense and what cannot be written off as an expense. These small errors will also lead to penalties and additional f

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

es associated with your filings.

Make sure to keep all receipts or online order forms for later reference and keep them organized. There is nothing worse than the end of the year sorting festival

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

Receipts get lost and records can be incomplete if not taken seriously. Do under estimate the power of organization and the process of organizing your records. Keep them tight!

Giving to charity

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

must also be carefully monitored and accounted for by both parties. The philanthropist and the charity should both get a receipt and have good records. If you give time then keep good logs of your

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

time and have the charity you donate to accept and sign for your log. You need a receipt!

Warning! Take great care not to fabricate or provide false deduction information. If you claim a deductio

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

make sure your records are in order and you are prepared to be questioned if such questions arise. The practice of over filing expenses with the federal government and fabrication of records is a

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

Following aspects would a

federal offense and can carry legal ramifications beyond penalties and fines.

In fact you can be imprisoned for fabrication of any information regarding your taxes. Going to prison for bad recor

dd to the challenges in developing combination products:

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

keeping? Now that is a bad way to end a fiscal year.

Keeping track of money coming in is as much of an issue as keeping track of money going out. Simple bank statement preservation can go a long

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

way to keeping things on track for your new business. Keep them in a “safe” place preferably a fire proof safe if possible. Remember all the responsibility rests squarely on your shoulders no on e

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

se's. The federal government does not care if your building burns to the ground before the tax year is over. You are still responsible for your taxes and the ramifications for not filing can be ex

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

ensive ones.

Good accounting software should be your first stop if you plan to keep you own accounting records. There are several packages out there some are expensive and some a cheap. Pick one

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

Professional from academic institutions, pharmaceutical industries, health care indust

hat meets your needs best not the biggest just because it appears to be the most expensive or the one with the most features. Remember, you have to learn how it works in order to keep good records

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

So keep in mind your own personal limitations when purchasing accounting software.

Finally, if you accept cash then document the transaction with a receipt. Never take cash without a receipt and

.

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

always claim your cash receipts at the end of the year. After all, the greatest Mafia bosses and organized criminals of our time were not prosecuted for murder or the other hideous crimes they wer

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

Companies that provide selfless information through particip

in charge of. They were imprisoned for not filing taxes on cash receipts.

A good accountant can help you to avoid penalties and over taxation. Hire one they are worth every penny in the long run

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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