Advice You - Business

During the past few years, we have heard a lot of whining in the media about outsourcing and offshoring. Let’s look for the opportun

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

ities in these irreversible trends (and ignore the whiners!).

By fully leveraging offshore talent (a strategic view of global sourc

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

Examples of combination products may in

ing) we can improve productivity, increase quality, and create American jobs. Yes, I said “create America jobs.”

An aggressive outs

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

ourcer in Pasadena, California named IndyMac Bankcorp has risen from the twenty-second largest U.S. mortgage issuer to the number-ni

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

e position in only three years. According to IndyMac’s CEO, they are more productive, more cost efficient, more flexible, and provid

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

Combination pro

e better customer service than the competition because of IndyMac’s outsourcing and offshoring partners. India’s Exlservice Holdings

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

(with a staff of 5,000) handles over 30 of IndyMac’s back-office processes, including bill collection and the “welcome calls” that

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

ssist American customers. IndyMac is also using New York-based Cognizant Technology Solutions Corporation to develop next-generation

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

software, which will increase productivity by as much as 20% by 2008. All of this outsourcing and offshoring has led to explosive g

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

rowth. IndyMac has doubled its American workforce, in just four years, to almost 6,000 jobs.

Charlotte-based Wachovia Corporation h

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

s a $1.1 billion deal with India’s Genpact to handle finance and accounting jobs, and a separate deal with Illinois-based Hewitt Ass

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

Following aspects would a

ociates to handle administrative and HR programs. But, it is not just about cost savings, it’s about growth! Wachovia plans to inves

dd to the challenges in developing combination products:

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

t up to 40% of the $600 million to $1 billion in savings in core business growth. Wachovia’s Director of Corporate Development belie

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

ves this is what is necessary to become a “great customer-relationship company.”

Eli Lilly and other “big pharma” companies are fac

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

ng unsustainable costs to develop new drugs. Lilly now does 20% of its chemistry work in China for one-quarter of the U.S. cost. Lil

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

ly plans to expand these efforts into Russia, China, India, and Brazil.

Many new companies are using outsourcing and offshoring fro

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

Professional from academic institutions, pharmaceutical industries, health care indust

m the start. California-based Crimson Consulting Group (with only 14 full-time employees) is able to compete with the world’s larges

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

consulting firms (including McKensey and Bain) by offshoring research. Crimson uses India-based Evalueserve, as well as independent

.

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

experts from around the world.

Wise leaders (and consultants) are now asking for articulate outsourcing/offshoring strategies. Are

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

Companies that provide selfless information through particip

you familiar with the wide array of business services, software development, and call center resources that are currently available

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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Take a little time off from work to replenish your energy and spend quality time with your family. Time is something most of us don't have enough of, so we need to schedule time in for our families when work gets too demanding.

Franchising is one of the popular business expansion systems in the world today. It has been around since ancient history but has only recently made its debut in the world market. Franchising as a business system in the US is very effective because although it accounts for only 8% of the total in retail business, it garners over 40% of the total retail sales.

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