Actual - Writing and Speaking

The modern business environment is based on strong commercial relationships and clear exchange of information. Despite the modern commu

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

nication channels (emails, newsletters, video conferences, etc) the old-fashioned letter still plays an important role in the informati

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

Examples of combination products may in

nal process.

Business letters are probably the most difficult to compose. They need a clear purpose and the writing style should be un

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

mbiguous and concise. When you write a business letter you have to “visualize” your reader and his/her availability and desire to read

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

our message. Business people are often too busy to read long rambling letters. So try to resist the temptation of writing too much and,

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

Combination pro

if you are “new at the job”, ask someone else to read and review the critical letters prior to sending them out.

To produce the ideal

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

business letter (and the same principles apply to other letters as well) you need to:

plan what you want to say – eventually m

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

ke some notes to structure your ideas before actually writing the letter;

write the letter – and avoid using slang, technica

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

and unusual terms, sarcasm (which is often misleading on paper and people might find it offensive);

read the letter out lou

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

d – by doing so you’ll get a better sense of the flow of your message and how it might sound to the person reading it;

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

out your letter and reread it – this time edit it by cutting out all the useless words and phrases: keep it short and simple; check you

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

Following aspects would a

spelling, punctuation and sentence structure;

make all the necessary corrections on the original copy, then send.

dd to the challenges in developing combination products:

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

A business letter has a standard structure, quite easy to summarize: the date, the official’s name and address, the correct salutation

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

, the body of the letter and your signature. The body of the letter at its turn has a pretty clear structure too:

in the openi

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

g paragraph you explain why you write;

in the next parts you stimulate the interest of the reader through a positive tone an

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

a clear presentation of your message;

in the ending paragraph you stimulate action from the reader by telling her/ him what i

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

Professional from academic institutions, pharmaceutical industries, health care indust

the next logical step.

There are many types of busine

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

ss letters. Among them the sales later requires the most advanced writing skills. Hopefully, after you write your first successful

.

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

tandard letters (acknowledgement letters, adjustment letters, complaint letters, inquiry or response letters, etc) you’ll be prepared t

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

Companies that provide selfless information through particip

take your skills to the next level. If you are still insecure, there are enough free tutorials and free samples online to help you out

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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