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Congratulations on deciding to be your own boss. Remember these three key points and you will be

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

on your way to a good start in your new home-based business.

Keep business & personal receipts

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

Examples of combination products may in

separate.

Open a credit card in your business name and use this for business, not personal expen

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

ses. If you are a sole proprietor and not using a ‘trading as’ name, pick one of your credit car

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 that you will use for business purposes only. Don’t mix business and personal charges on any of

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

Combination pro

your credit cards. Even if you are shopping, and have items in your cart that are business purch

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

ases, have the cashier ring two separate sales so you can charge one to your business card and th

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

e other to your personal card. While the people in line may give you dirty looks, you can console

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

yourself with the fact that you are making purchases that will help reduce your taxable income, w

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

hile theirs probably are not.

Open a separate business checking account.

Deposit all checks fro

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

m your customers into this account and use it to pay all of your business expenses. If you are e

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

Following aspects would a

ver audited, this shows the IRS that you treat your side business as a real company, with all the

dd to the challenges in developing combination products:

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

bookkeeping that goes with it. If you have a ‘trading as’ name, your bank will most likely requir

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

e you to open a business account. However, if you use your name as your business, you can open a

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

new personal account and save on the bank service charges you would be charged for a business ac

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

count.

Apply for all business licenses that pertain to your business.

If you operate a home-bas

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

Professional from academic institutions, pharmaceutical industries, health care indust

d business, be sure to obtain any licenses that are required from your local government. Check y

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

our state’s website for information regarding any legal aspects regarding opening and operating y

.

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

our business. You want to make sure you are fulfilling all legal requirements for a home-based b

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

Companies that provide selfless information through particip

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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“Silent Career Killers” are the things that nobody comes right out and tells you about in professional circles. If you know about them, you can keep from making serious mistakes in your career. But if you don’t address them, they will absolutely prevent you from advancing.

This article explains Dr Barry Johnson's theory of Polarity Management. It explains how to identify the difference between a problem and a polarity and when to solve a problem or manage a polarity.

People hide from eachother in public. They do not make eye contact and never smile at anyone. If you were to smile, it could lead to a conversation, and that could lead to making a friend. Opportunities come from people, thus, you want to know more folks!

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