Advice You - Business

Before clarifying the difference between offshoring and offshoring 2.0, let me, first, introduce the notion of outsourcing. It was exactly this

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

business process, which laid the foundation to offshoring. The idea of outsourcing was born when some big companies decided to get rid of some

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

Examples of combination products may in

routine work which, they thought, could be performed by some third parties for money. That is how they started outsourcing everything but core

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

usiness activities to other companies, yet within national boundaries.

Some time later huge imbalance in global economy prompted them another

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

olution. Why not reduce costs by sending all outsourced work abroad? By that time, people from developing countries had already started opening

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

Combination pro

up offshoring companies, offering their offshoring services to their post-industrial partners. The process was two-way profitable. On the one h

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

and, the cost of labour in developing countries is cheaper than in post-industrial countries. It was a benefit for the companies, which shifted

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

their work abroad, because they could down their costs. On the other hand, these foreign companies paid more to offshoring companies than a nat

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

onal company would pay.

That is how the idea of offshoring was born. First, low-skilled service jobs like telephone call centres, component as

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

embly were handled over to offshoring companies. Later on, offshoring companies started taking up more complicated tasks, and proved that they

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

ould perform them on the same level as their colleagues from post-industrial countries, or even better.

With the arrival of the digital age Of

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

Following aspects would a

fshoring 2.0 appeared. Because digital communications have become more accessible and affordable, many partner offshoring companies, have becom

dd to the challenges in developing combination products:

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

able to do even more for their clients than before.

If later, outsourcing offshoring companies were involved in all kinds of outsourcing, now

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

they have become more specialized. Here lies the main difference between Offshoring and Offshoring 2.0. Today there is a row of offshoring comp

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

nies, which deal with one particular type of tasks, i.e. software development, web development engineering, financial analysis etc. Some say th

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

t such professional classes as lawyers, accountants, computer programmers will soon disappear in post-industrial countries, because all their w

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

Professional from academic institutions, pharmaceutical industries, health care indust

ork will be outsourced to outside countries!

Thanks to their narrow specialization, say, web development, offshoring companies get a nice oppo

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

tunity to master correspondent skills and, thus, do their job on a highly professional level. Rather than handling everything without having 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

p knowledge and enough experience, having narrow specialization proves to be more advantageous to the company itself and its clients.

Offshori

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

Companies that provide selfless information through particip

g 2.0 is only starting to open up great opportunities, but already, now, it promises to become the greatest business process of the XXI century

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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Life is not always how we want it to be. There are many ups and downs. Sometimes we pursue career options, which are different from those, which we had imagined, or those that our parents would like us to be.

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Advice You - Offshoring and Offshoring 2.0: What's the Difference?

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