Main Subject - Business

Let’s get one thing straight; I’m not prejudice or racist. But I have trouble understanding certain cultures that have strong accents. In an a

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

ttempt to keep costs down, many computer hardware and software firms have redirected their support to India and other Asian nations.

The resu

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

Examples of combination products may in

lt can be frustrating to both sides of the phone call. I recently needed to seek out a tech support (TS) person and was guided to an online 80

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

0 number. The conversation went something like this.

TS: Ken I hup you?
Me: Yes, I have a problem with my mail serve

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

TS: I ken teck ceh off dat. Whut ees your suscrivner nomva?

Me: Excuse me?

TS: Your suscrivner nomva?

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

Combination pro

Me: Huh?

TS: I am sari you hour habing trebel anderstendink me. I neet your sascribner nomver?

Me: Oh, my su

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

bscriber number. It’s 2468990.

TS: You hour meester Howzair?

Me: Yes.

TS: Wery gud. Now, whut ees da prabl

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

Me: I can’t access my email. The server says it’s down.

TS: Dat ees too bed. Pleez tal me whut eet sayz.

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

Me: It says that there is an error.

TS: Wat cand uv ovaretin seesteem hour you youzink?

Me: Excuse me?

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

S: I am sari you hour steel nut anderstendink me. I neet to na your ovaretin seesteem.

Me: I’m sorry, what was that?

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

: Your seesteem. Ees it a peecee or a mec?

Me: Oh, my operating system. It’s a Mac and I’m using Panther 10.3.

TS: Da

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

Following aspects would a

nk you. I am nut fary wamilar wit da mec.

Me: Really?.

TS: Eet be ulreet, boot av you con een to da pravarianses and r

dd to the challenges in developing combination products:

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

amoofed dem to da drash?

Me: Huh?

TS: I am sari you hour steel nut anderstendink me. Hour you wamilar wit da pravarian

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

ses fail?

Me: Sorry, please repeat?

TS: I am sari. Da pravarianses fail?

Me: Once more, if you please?

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

TS: I sari. I spill far you. P-r-e-f-e-r-e-n-c-e-s f-i-l-e.

Me: Oh the preferences file. Sure. I know where that is.

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

li> TS: Gud, Pleeze ramoof da pravarianses fail due da drash end ristard. Den you ned to wet far dee nacks tep frum me eftar you tal me you

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

Professional from academic institutions, pharmaceutical industries, health care indust

half dun dis furse pert. Due you anderstend? This was just the first five minutes of an hour call. I have no beef with anyone w

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

o attempts to speak English, who has been raised in a foreign land. But I plead with all those companies that think they are saving a buck or

.

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

two per hour by utilizing oversees techs for their toll-free support. Am I the sole voice or reason in this insane age? I don’t think so. Let’

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

Companies that provide selfless information through particip

s return to normality and give us the support we deserve. Now, a final to all those companies that fall into that category; hour you lessunink

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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Paralegals – also known as legal assistants – help attorneys in almost every aspect of their work. Being one of the fastest growing careers nationwide, those with paralegal training will be able to find jobs in every part of the country.

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Main Subject - Outsourcing Tech Support Overseas: I Can't Hear You

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