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A number of people have realised the dream of owning and operating an independent business. These people continue to embark on one of the most exhila

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

rating and one of the most frightening adventures ever known: launching a business. It is never easy, but it can be incredibly rewarding, both financ

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

Examples of combination products may in

ally and emotionally.

Who are these entrepreneurs, and what drives them to work so hard with no guarantee of success? What force lead them them to r

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

sk so much and to make so many sacrifices in an attempt to achieve a goal? Why are they willing to give up the security of a "steady pay cheque" work

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

ng for someone else to become "the last person to be paid" in their own company.

THE ENTREPRENEUR An entrepreneur is a per

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

Combination pro

son who creates a new business in the face of risk and uncertainty for the purpose of achieving profit and growth by identifying opportunities and a

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

sembling the necessary resources to capitalise on those opportunities.

Starting and running your own business involves both management and entrepren

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

urship. When you develop a product, for example an electric rocking chair, you are initiating an innovative change and you are acting as an entrepren

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

ur. However when you start producing this electric rocking chair, you begin to act more like a manager than an entrepreneur, co-ordinating and contro

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

lling the business operations.

THE INTRAPRENEUR

An intrapreneur is an entrepreneur who has no need to start his own busines

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

but wishes to use his business skills in an existing business. Intrapreneurship involves identifying an opportunity within an existing business and

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

Following aspects would a

reating a profitable reality for the business from this opportunity. In other words, an intrapreneur is someone who prefers the benefits of an existi

dd to the challenges in developing combination products:

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

g business (such as a regular salary and available resources) to the uncertainties of a business of his own.

The role of entrepreneurs and i

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

ntrapreneurs

An entrepreneur can be described as someone who:

1. starts his/her own business

2. manages his/her own business

3. i

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

entifies new products/services or opportunities

4. is creative and innovative

5. organises and controls resources to ensure a profit for the busine

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

s

6. has the ability and insight to market, produce and finance a service or product

7. who has financial means or who can obtain financing so as t

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

Professional from academic institutions, pharmaceutical industries, health care indust

realise the business

8. who is willing to take calculated risks

An intrapreneur can be described as someone who:

1. manages an existing bu

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

siness

2. is appointed by the owner of a business enterprise to manage the business

3. identifies new products/services or opportunities for an exi

.

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

ting business

4. is creative and/or innovative with the ability and insight to market, produce and finance a service or product

5. organises and co

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

Companies that provide selfless information through particip

trols resources to ensure a profit for the existing business

6. prefers the benefits of an existing business such as a salary and available resource

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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If you are looking for a job in cannot find one then there is a government job ready for you. The government continually wastes taxpayer's money and hires people needlessly to push around paper. Of course we all know the government

Think about the situation where your company is receiving more phone calls than it can handle, not for one day but every day for weeks, the customers and prospects are waiting minutes of valuable time. They will loose their patience. And your company is losing even more - You can solve a mathematical problem ending up with a solution. If your organization is facing a change, than the problem solving equation is more complex -And you are there in front of a decision to take

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