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Are you planning to set up a translation business? Then there are two or three fundamental questions you will need to consider if you want your business to be a success. One of these, and in fact the most obvious one, is how to attract

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

clients. However, the marketing effort and insight needed to tackle the issue of client acquisition is the subject of another article. In this specific issue I would like to concentrate on a fundamental dilemma that many self-employed t

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

Examples of combination products may in

ranslators will face: to work as a freelancer or to take staff on board.

The answer to this question depends in part on you ambitions as a translator. If translation is a job on the side for you, if you are able to combine your transla

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

tion work with a host of related business concerns, from technical to administrative, and if you don’t mind working in solitary confinement, then it is probably a good idea for you to set up shop as a freelancer. From that position you

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

will be able to work for translation agencies and specific clients alike, decide for yourself how much work to take on and when to take days off. One drawback is that you will not always be able to satisfy your clients, especially in te

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

Combination pro

rms of volume, forcing them to also engage the services of other translators who may be more specialised or have more capacity. Another drawback is that you will generally be working on your own, without the company of colleagues to cha

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

t with or consult. Most of the people you do get in contact with will probably never be known to you other than as a person at the other end of the telephone line. In addition, you will always be responsible for all the aspects of your

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

business, without having the possibility to delegate tasks to people who may be more suitable for them than yourself. This means, for example, that you will have to generate your own business and find ways of attracting clients. On the

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

upside, however, if your translation work is of good quality and you acquire a reputation as a reliable partner, even among a few clients, then you may soon find that business generates itself.

If a freelance existence does not appeal

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

to you, one alternative is to hire people – translators or other specialists – and to become an employer, rather than principally a translator. This strategy offers a number of obvious and significant benefits. The most important advant

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

ge is that by setting up a team you will be able to generate far more turnover than as a freelancer – provided that you generate sufficient business to keep the team running. By multiplying your translation capacity you will be in a muc

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

Following aspects would a

h better position to land large-scale orders. If you also manage to find high-quality marketing & sales specialists, moreover, you will be able to convince bigger, high-profile companies of your professional approach and ensure them of

dd to the challenges in developing combination products:

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

the continuity of your business, even when you are not there yourself.

There is an adage that says that big companies prefer to do business with big partners, and even if there are many exceptions to that rule, there is no denying that

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

highly reputed global businesses will obviously tend to select high-profile suppliers for whatever it is they might want to purchase. Even so, you don’t need to be a mega-employer to provide translation services to major industry names

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

. In the commercial translation business, individual agencies with five employees already count and those with twenty or more are the major players.

Of course, employees are a mixed blessing. They will need to be seen to. Employees nee

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

d attention, encouragement, and guidance. Even if no problems occur, you may find that you are spending more time sorting out employee-related administrative matters than working as a translator – unless of course you hire other employe

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

Professional from academic institutions, pharmaceutical industries, health care indust

es who can look after employee issues. As long as business is booming – which it may well be if your agency is run effectively, because demand for translation services is immense – there is a risk of ending up in an employment spiral. T

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

he dialectics of progress rule that the more you grow, the less benefit your growth will bring, so clearly this is a situation you want to avoid. Carefully controlled expansion is crucial.

In summary, a freelance business offers a grea

.

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

t deal of personal freedom but imposes clear and inevitable limits to the scope of your work. Another downside is that it condemns you to a solitary and essentially domestic career. If you prefer a more dynamic business environment and

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

Companies that provide selfless information through particip

do not fear employee issues or serious competition, you might consider setting up an agency and taking on people to work for you. The size and success of your business will ultimately depend on your professional and commercial ambitions

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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