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Enterprise architecture integrates the general decisions that have to be made within an organization. It hel

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

ps to build an information support system. Enterprise architecture acts as a master plan that coordinates th

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

Examples of combination products may in

different aspects of a business enterprise. These are the goals, objectives and strategies adopted in the b

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

siness planning process. It also includes the business terms, organization structures, processes and data in

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

business operations, application systems and databases involved in automation. The computer operating system

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

Combination pro

and network frame the technological infrastructure.

Enterprise architecture is an IT frame creation that 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

sists in managing and reorganizing the different processes of an organization. It enables the personnel to m

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

ake a business logic sketch and assists in converting the business objectives of the company into technology

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

assisted systems.

Enterprise architecture is divided into business, data, application and technical archite

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

ture. It helps to address various issues involved in the business process, where the main objective is to de

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

iver business solutions. Enterprise architecture has different applications for the different facets of a bu

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

Following aspects would a

iness enterprise. It helps in organizational learning, strategic planning, organizational design, competitiv

dd to the challenges in developing combination products:

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

advantage, business process re-engineering, and systems delivery.

Most business enterprises prosper on int

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

llectual capital and not equipment or machinery. People who contribute new ideas, knowledge and skill are co

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

unted as assets. These intellectual assets of the business exceed the value of assets that appear on the bal

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

nce sheet. The ability to tap these intellectual assets requires structural and intellectual assets such as

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

Professional from academic institutions, pharmaceutical industries, health care indust

anuals and software. Enterprise architecture helps to procure and explore the structural intellectual assets

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

In the business being conducted these days, the focus is to reduce product development time. This architec

.

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

ure helps in the product differentiation, at a low cost. Enterprise architecture also assists in business pr

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

Companies that provide selfless information through particip

cess re-engineering and is very useful in providing the necessary information to facilitate desired progress

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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