Useful Advices - Business

Writing white papers is not an easy task for most companies, but every company needs them to effectively educate and market their

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

products and services to potential customers. In many cases, white papers contain additional information and extra analyses, whic

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

Examples of combination products may in

aren’t included in other advertising or marketing materials. Your business can utilize white papers to reach a wider audience, b

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

ut first you need to ask yourself these important questions:

1-Who is your audience? Make sure you analyze and define your

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

audience, so you can effectively convey your technical or business concepts to the reader. If needed, you can include an extra se

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

Combination pro

tion of your paper called “Intended Audience” in the body of your white paper.

2-Did you create an outline? It’s a good i

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

dea to structure your white paper accordingly, so that you present a solution to your business/industry problem. To use your time

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

wisely, I would recommend that you get your outline reviewed by experts of the subject before writing the entire paper. Make sure

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

to have supporting evidence to support your argument as well. Key components of a white paper should include the cover page, exec

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

tive summary, table of contents, body, summary & call to action, and lastly, the author’s biography or works cited page. It is im

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

ortant to make sure that your executive summary is clear and understandable, so that the reader can follow your in-depth descripti

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

Following aspects would a

on of your business problem in the following sections of your white paper.

3-Did you explain your diagrams or flow charts?

dd to the challenges in developing combination products:

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

Many white papers include diagrams and flow charts. These require a thorough description and explanation. Make sure these diagr

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

ams are easy to follow and not too technical for the reader.

4-What kind of writing style are you using? White papers are

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

essentially marketing materials, but a little more meaty. Make sure the white paper is readable, but also beware of marketing-spe

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

k. White papers are typically more formal, but try to minimize technical jargon. Also, in developing the style of your white pape

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

Professional from academic institutions, pharmaceutical industries, health care indust

r, you should also identify what type of white paper you’re writing.

5-What is the length? The shorter your paper, the bet

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

er. You want to make sure that the paper explains the complexity of your product or method, but it should never be longer than 15

.

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

-pages.

For more information on white paper guidelines:

http://www.whitepapersource.com/writing/7steps.html

http://www.klariti.

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

Companies that provide selfless information through particip

om/business-writing/more-guidelines-white-papers.shtml

http://www.nwcg.gov/teams/pmo/products/documents/White_Paper_Guidelines.pd

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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