Useful Advices - Business

Geroge Castanza
523 Duplex Avenue
Toronto, Ontario, Canada

M4R 1V7

Res:

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

(416) 482-2222 / (705) 733-7845
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; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

GeorgeCastanza@hotmail.com

Dear Sir/Madam,

I am currently completing a Masters o

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

f Business Administration in International Marketing at Northwood University in Midlan

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

, Michigan. For this M.B.A., I am doing research and class presentations on automotive

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

Combination pro

companies and other corporations. I hold a Bachelors degree in Business Administration

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

, Automotive Marketing from Northwood University and two Business and Marketing diplom

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

s from Georgian College: The Canadian Automotive Institute Diploma (automotive marketi

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

ng) and also a Diploma in Business Management and Marketing from Georgian College - Ba

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

rie, Ontario. I now wish to express my strong interest in seeking a challenging new ca

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

eer opportunity with your organization. Please find my resume enclosed.

Being a multi

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

Following aspects would a

-task oriented team member with a high energy level, I have demonstrated considerable

dd to the challenges in developing combination products:

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

uccess in identifying concerns and discrepancies to establish effective results. I am

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

able to maintain attention to detail and I am skilled at adjusting quickly to changing

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

requirements while working towards objectives. My strengths include excellent communic

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

tion and intra/interpersonal abilities and I realize the need for good interaction at

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

Professional from academic institutions, pharmaceutical industries, health care indust

all levels. I am always interested in extending my skill base.

I feel confident that

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

can make a contribution to your organization. I would appreciate the opportunity to p

.

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

ersonally discuss your requirements and my ability to meet them.

Thank you for your t

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

Companies that provide selfless information through particip

me and consideration. I look forward to speaking with you.

Sincerely,

George Castanz

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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