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Having a strong foundation enables you to build a thriving, profitable life and business. A simple method to create this foundation is with Discovery, Vision, Planning and

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

Benchmarking, the four cornerstones of your life as well as your business.

Discovery is defined as examining where are you now and where are you going. It helps to look

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

Examples of combination products may in

t everything as if you were a beginner. Always know why you are in the business of your choice. If your strategy is not clear, you won't recognize the destination when

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

you get there. This is the time to bring in your outside Vision Team.

Vision is who you are about and what your life is about. This is where you determine values you need

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

o experience on a continuing basis. Vision is also where you become the expert in your field and decide the purpose of your business. Remember, the smaller the niche, the

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

Combination pro

larger the reward. Abandon any preconceived beliefs you have about this or any other business. They can restrict your thinking. Live out of this new vision, not your past

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

comfort.

Planning creates the strategies that help you arrive at your destination. A simple system is to - Show Up, Be on Time, Keep Your Word and Tell The Truth. It's

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

like riding on that train, sometimes there are hills to climb; sometimes there are curves and other times you're flying rapidly down the mountain to your destination. In

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

ny instance, you must remain focused on what you want and where you are going.

Benchmarking helps you stay on track. Once focused, you set up a system for accountabilit

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

y, self-management and self-renewal. You can create outcomes or optimum wants that may be on the outer edge of possibilities or a result that is far bigger than you thi

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

k is attainable. Going into new territory can unlock your potential and increase your development. When outcomes or optimum results are achieved, you can acknowledge succe

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

Following aspects would a

s and learn to be satisfied. Again, put it in writing; the outcomes, the results and the acknowledgement.

Rules require exceptions, so even if you follow the above and cr

dd to the challenges in developing combination products:

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

eate a strong foundation, you must be prepared for chaos. Chaos can aid in your personal and business development if you have eliminated all toxic people or commitments

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

from your life.

Chaos can then become the opportunity to progress rapidly into new territory. You can be the architect of your own life.

With a strong foundation, you can

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

build anything.

~.~.~.~

Joanne Victoria works with small business owners who want to achieve more and still be true to who they really are. Sign up now for her FREE mont

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

hly e-zine Create the Business of your Dreams at: mailto:CreateYourBusiness-subscribe@topica.com

Joanne Victoria Tel: 415-491-1344 mailto:joanne@joannevictoria.com A

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

Professional from academic institutions, pharmaceutical industries, health care indust

thor of : Lighting Your Path! How To Create the Life You Want - Order Here! http://www.joannevictoria.com ~.~.~.~.

Article Title: Create A Blueprint For Your Success A

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

thor Name: Joanne Victoria Contact E-mail Address: mailto:joanne@joannevictoria.com Word Count: 487, wrapped at 60 characters Category: Business Development Copyright Dat

.

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

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

Companies that provide selfless information through particip

of publication by sending either a website link or a copy of your ezine upon publication to: mailto:joanne@joannevictoria.com . ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

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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Before any document is finalized, you need to let someone else take a look at it. I cannot stress enough the significance of this step! Letters, memos, reports, brochures, even important e-mails—any writing that will see the light of day—should be read by others before you send it off. Here's why.

It's the question that is on the minds of all our customers regardless of what products or services we are offering. Potential customers want to know what makes you so different and why should they do business with you as opposed to one of your competitor's.

Many business owners have no sense of the tremendous liability of waiting to start marketing. When you're not moving forward, you're losing ground.

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