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Digg It - Outsourcing Trends in Europe
European companies are finding financial benefits to outsourcing and are doing it more and more. The primary difference between American and European outsourcing is nearness. When an
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
American company does offshore outsourcing, very little consideration is ever given to nearness of the vendor company. Technological developments have made this statistic negligible.
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
So why do European companies look for outsourcing destinations closer to home? For one, they see benefits in having the people to service their customers be personally familiar with th
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
eir culture. They find comfort in the vendor company being in the same time zone. But perhaps the biggest consideration is language. This is something the American outsourcing compan
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ies don’t have to worry too much about, because the English is spoken widely throughout the world. In addition, vendor companies wishing to secure American business have their own Engl
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ish training processes for employees.
One of the biggest areas of European “nearshore” outsourcing is the IT function. These can be classified into three types of outsourcing: project
One of the biggest areas of European “nearshore” outsourcing is the IT function. These can be classified into three types of outsourcing: project
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
based, dedicated center and captive operations.
The most common is project-based outsourcing. This is where the vendor company is hired to run or assist in completing a specific, usu
The most common is project-based outsourcing. This is where the vendor company is hired to run or assist in completing a specific, usu
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
ally long-term project. When the project and all follow-up work are complete, the relationship between the hiring company and nearshore outsourcing destination company is over.
The “c
The “c
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
aptive operations” type of outsourcing is where the company sets up its own office in the nearshore location, usually an Eastern European country. There they hire native workers, but s
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
till management from their own country. This is possibly the most risky strategy in terms of investment capital required, operational efficiency and organizational issues. This path i
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
s sometimes appropriate for large and multinational companies prepared to take these risks and familiar and ready for the personnel and staffing issues.
A growing strategy is that of “
A growing strategy is that of “
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
dedicated development centers” (DDCs) which is less costly than the captive operations strategy, but works well in a long-term relationship approach. DDC involves having full-time deve
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
lopers working exclusively on client projects for a prolonged period of time. Although technically these people work for the vendor company, it is like having a virtual extension of th
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
e client office in the nearshore country.
DDCs can be further categorized. A dedicated team model, for example, is very common. In this model the vendor provides the facilities and a
DDCs can be further categorized. A dedicated team model, for example, is very common. In this model the vendor provides the facilities and a
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
llocates the team, but the client has full operational control.
The term “tailored DDC” is used to describe a facility tailored to the custom business model, with specific technology n
The term “tailored DDC” is used to describe a facility tailored to the custom business model, with specific technology n
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
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
eeds and perhaps special organizational structure. These can be product development centers, research and development centers, software maintenance and support centers, application ree
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ngineering centers, quality assurance centers, etc.
A joint venture DDC is often a transitional stage working towards a captive operations style of outsourcing. Both vendor and custom
A joint venture DDC is often a transitional stage working towards a captive operations style of outsourcing. Both vendor and custom
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
er support it. They share the risks and responsibilities.
The “build-operate-transfer” option is similar to the joint venture DDC. In this case it is designed, specifically, to be tu
The “build-operate-transfer” option is similar to the joint venture DDC. In this case it is designed, specifically, to be tu
.
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
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
rned into a captive operation. The vendor sets up the business infrastructure, hires personnel and establishes and runs the center for a predetermined length of time. Afterwards this
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
facility is turned over completely to the client.
Many European companies wanting to outsource all or some of their IT functions are turning to one of these methods of DDC outsourcing.
Many European companies wanting to outsource all or some of their IT functions are turning to one of these methods of DDC outsourcing.
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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