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1. Will your translation company provide proofreading free of charge o

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

r will quality control be performed in an alternate fashion?

2. How d

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

Examples of combination products may in

es your translation/localization firm count the volume of the source t

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

ext to be translated? This could be shown in terms of number of words,

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

number of pages, or number of sentences?

3. Are your translation team

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

Combination pro

members exclusively residing in-house i.e, in the office or are they a

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

lso consisting of outsourced translators or a combination of both?

4.

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

How long have your translators been translating, on average and what a

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

e your credentials, and/or qualifications. Some translation agencies a

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

re members of what is known as the ATA or American Translation Associa

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

ion, which oversees professional translators.

5. Can you offer my org

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

Following aspects would a

nization any kind of past references of medium/large translation proje

dd to the challenges in developing combination products:

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

cts which your firm has successfully undertaken relating to my area of

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

need?

6. Are your translators not just qualified to translate the lan

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

uage itself, but the specific subject matter i.e., engineering, IT, li

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

terature, along with all possible nuances to effectively render the or

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

Professional from academic institutions, pharmaceutical industries, health care indust

ginal meaning of the source dialogue?

7. What kind of discount would

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

ou be willing to offer me as a first time client and potential ongoing

.

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

customer? Don't be afraid to try and negotiate as translation compani

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

Companies that provide selfless information through particip

s are known for cutting their rates to satisfy their potential clients

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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