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The simple answer to this question is yes, no and maybe. Well, maybe it is not such a simple answer because it is a particularly loaded question. The subject of outsourcing is a very sensitive issue for many. There

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

are some who believe that outsourcing, whether it is overseas or domestic, is taking jobs away from qualified individuals while others who are profiting from outsourcing are firm advocates for the practice. This art

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

Examples of combination products may in

cle will take a look at outsourcing and will examine scenarios when quality is compromised as well as scenarios when quality is not compromised.

First of all, what is Outsourcing?

For those who are confused about

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

what outsourcing entails, this section will explain the issue. In its most basic form, outsourcing is employing an individual outside of the work organization to perform specific tasks for monetary compensation. Out

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

ourcing can be done on a per project basis, for a set period of time or on an ongoing basis for an undetermined period of time. Another term you may be familiar with is consulting. You may use a consultant, or expe

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

Combination pro

rt, in a particular area to perform a task or project on your behalf.

For many the word outsourcing has a very negative connotation. When they think of outsourcing, they picture underage employees in third world co

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

ntries working for salaries which would be paltry by our standards. However, outsourcing has evolved so much and no longer resembles this stereotype. In fact a great deal of outsourcing takes place domestically by s

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

avvy entrepreneurs who market their abilities as an independent contractor rather than toiling away in corporate America. These individuals enjoy their quality of life, negotiate fair compensation for their work and

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

accept or decline work at their own will. Furthermore these individuals are often highly qualified for the positions they accept and are capable of producing work of a high standard.

When does outsourcing compromis

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

es quality?

The simplest answer to this question is quality is compromised when price becomes the sole governing factor in selecting a candidate to complete the outsourced task. Of course this answer is not complet

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

ly accurate because the truth is there are very educated and skilled employees overseas who are fully capable of completing tasks just as well as those living in this country and often for a much lower price. Howeve

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

Following aspects would a

, when only domestic candidates are being considered and price is the governing factor, quality is often compromised as it is very rare that the most qualified candidate is also the candidate with the lowest rates.

dd to the challenges in developing combination products:

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

However, it is very common for an individual or a business to allow price to become more important than quality of work. When this happens quality is often compromised for the sake of a larger profit. An example of

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

this is seen regularly on websites where outsourcing projects are listed and potential applicants submit their bids for these projects. Many who utilize these websites routinely select the lowest bidder without rega

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

rd for the qualifications of the bidder. In most cases these individuals find they make a costly mistake when the work they receive is inadequate.

When does outsourcing not compromise quality?

Outsourcing does not

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

always compromise quality. In fact in many cases outsourcing is not only the most affordable option but also provides the most qualified candidates. One way to avoid the pitfalls of having quality compromised by out

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

Professional from academic institutions, pharmaceutical industries, health care indust

sourcing is to carefully screen candidates before making a decision. This process should be taken just as seriously as hiring a full time employee because the work of the individual will reflect on you as an individ

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

al or your business. If due diligence is given to selecting the right candidate it is not likely that quality will be compromised.

When outsourcing work to an individual it is important to request detailed informat

.

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

ion regarding their qualifications and to verify all information supplied. Examples of information to request include:

* Previous work history
* Relevant work experiences
* Explanation of qualif

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

Companies that provide selfless information through particip

cations

Additionally, it is wise to ask for both business and personal references. These references should all be contacted and questioned about the work ethic and personal integrity of the individual

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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