Main Subject - Business

The query letter is simply a business letter that serves a dual purpose. It is an introduction of you to an agent, and an inquiry as to whether

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

the agent would be interested in seeing a particular piece of your work. The query letter is the first "picture" an agent will have of you an

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

Examples of combination products may in

d your work; and is perhaps your strongest selling tool.

Why the query letter? Basically it serves to save time. Agents and publishers simply

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

do not have the time to read unsolicited manuscripts, and it is certainly a waste of your time (and money) to make copies and send manuscripts

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

out to numerous agents knowing that most, if not all, will be sent back, left unread or perhaps discarded. So how do these opposing forces fina

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

Combination pro

lly meet up? The query letter!

Keep in mind the query letter is a sales tool. You will be selling yourself and your work and you must do so in

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

a polite and professional manner - but sell, you must!

A good query letter has three basic parts. The first paragraphs focus on selling the wo

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

rk. This part should be thorough and convincing, yet brief (not always easy to do). It should contain the type of work your presenting, where a

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

nd when it is set, and a general idea of the plot.

The second part of your letter should be spent selling yourself. List your writing credits 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

nd any information pertinent to that particular work. If you do not have any writing credits, explain your expertise with the subject matter. M

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

ention any writer's groups or associations of which you are a member. However, only relate information that is pertinent to your writing and th

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

Following aspects would a

e particular work you are promoting - do not include personal information.

In the third part of the Query you should mention whether the work i

dd to the challenges in developing combination products:

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

s in progress or completed (rule-of-thumb: everything except non-fiction should be in completed form.), when you can have it in the agent's han

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

ds, and your contact information. Suggest he/she contact you either by telephone or by the enclosed SASE (always enclose a SASE, this is a cou

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

rtesy most editors insist upon.), whichever is most convenient.

Go over your letter with a fine-tooth-comb. You don't want any typo's, or wrong

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

information; and make sure you haven't left out any pertinent information. Your first impression must be a good one - a professional on

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

Professional from academic institutions, pharmaceutical industries, health care indust

e.

If you want to know how soon you will get a response, it depends on the agent and his/her backlog. It could be anywhere from two to six wee

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

ks, possibly more - which is why you query many agents rather than waiting for an answer from one before sending to another. This is normal pra

.

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

ctice. If, however, several agents ask to see your manuscript you should not send it to more than one at a time. At this point in the process y

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

Companies that provide selfless information through particip

ou should have spoken with the agents and made a decision as to who you feel would be best suited to your needs.

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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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