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Practical tips for start-ups in the translation business

Although in fact it ended only two decades ago, the era of handwritten or typewriter

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

translations is one that most of us are not nostalgic about – if they remember it at all. To any modern-day translator, versed in – and addic

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

Examples of combination products may in

ted to – the cut-and-paste functionality of the latest word processing software, it is almost unimaginable there was ever a time in which tran

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

slations were produced with a pencil and an eraser, or with a typewriter and correcting fluid. Having said that, there is no denying that the

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

translation process has remained extremely labour intensive.

PCs are obvious and indispensable tools in the modern translation business. The

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

Combination pro

computerisation of our business has enabled us to become far more productive and to produce more polished texts which, thanks to the immense b

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

ody of ‘googleable’ reference material, are probably also more sector-authentic than our output of, say, fifteen years ago. Even so, not all b

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

siness owners are aware that in addition to advanced word processing software, a host of other tools have become available to make the transla

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

tion process more efficient. Here are a few tips.

1. Make sure to get digital versions of as many reference works as possible. Many dictionar

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

ies, encyclopaedias and the like are also available on CD. This will save you the trouble of leafing through weighty tomes, and help you find

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

the term you need with a few clicks on your mouse.

2. Get hold of high-quality terminology database software (TRADOS or another reliable bran

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

Following aspects would a

d). Even though it will take some time to build up your customised databases, once they have reached a critical volume they will help you use

dd to the challenges in developing combination products:

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

customer-specific terminology consistently and retrieve it in no time at all.

3. Ask your client about his lay-out requirements. Especially i

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

n the case of documents in exotic formats, it would be a pity and a waste of time if you went to the trouble of copying complex lay-out featur

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

s while your client would in fact, for editing purposes, have preferred a plain lay-out.

4. Try to find out if your client has already produc

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

ed documents similar to the one you are translating and, if so, ask if you can have a copy. This will prevent you from reinventing the wheel,

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

Professional from academic institutions, pharmaceutical industries, health care indust

and will ensure consistency with the client’s existing terminology.

It is interesting to note, finally, that while all sorts of tools have he

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

lped us speed up the process, the actual translation process itself has so far not been computerised to any significant degree. Most of the ef

.

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

forts aimed at automating the translation mechanism are focused on reproduction rather than creation. Translation is, and will probably remai

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

Companies that provide selfless information through particip

n for a long time to come, a purely cognitive skill that is performed inside the translator’s brain and that no amount of software can replace

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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