Social Space - Writing and Speaking

One of the most difficult tasks for the person who is in need of the services of a high quality author

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

is determining just who can do the work. Being capable is one thing, being available

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

Examples of combination products may in

to do the work is another thing.

There are several things that you, the hiring party, can do t

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

o ensure that you find a capable and available author:

1. Does the author have experience? Im

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

ortantly, is he or she able to write on the proposed topic? A good author will have samples of his or h

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

Combination pro

er work readily available for your perusal. Do not assume that all of the author's work is posted onlin

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

e; sometimes "we" authors hold our best work back from the public due to fears of piracy or because of

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

hird party confidentiality.

2. If the author is to cover a topic outside of their areas of expertise a

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

re you willing to pay extra for the research the author may need to do in order to accomplish the task?

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

3. Is the author available to work on your project now or is he or she presently busy with other assi

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

nments? How tight is your deadline? Can you work with the author's schedule or is your schedule not fle

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

Following aspects would a

xible? Would you consider using the same author at a future date for a different project if no agreemen

dd to the challenges in developing combination products:

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

t can be made to do the current project?

4. Does the author have references? Can you get a person's na

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

me and phone number and contact them about their work?

5. How much does the author expect to be paid?

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

oes the author list on his or her website a pricing structure? Can you get an ironclad estimate? What p

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

ayment methods are expected?

6. Is the author writing as a ghostwriter or do you want the author to us

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

Professional from academic institutions, pharmaceutical industries, health care indust

e his or her name and submit the articles to article directories for links back to your site?

As an au

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

hor, before I accept any assignment I prefer to discuss over the telephone details of what the hiring p

.

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

arty wants, what I can do for this person, and attempt to get a better feel for the job. I do not hard

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

Companies that provide selfless information through particip

sell my work; if someone is interested in my capabilities then we move forward. If not, we both move on

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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