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Your mission, legal assistants, should you decide to accept it, is to handle many of your boss’ phone calls. A good legal assistant continually strives to free up the at

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

torney’s time for court appearances, meetings, and more in-depth legal research. After all, this is how an attorney earns his fees. But in order to have fees that can b

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

Examples of combination products may in

e earned, new work must materialize. The majority of new work for attorneys comes in the form of phone calls. Handle these phone calls wisely.

The ability to filter th

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

rough types of phone calls and handle as much of the phone work as possible, with finesse, is an excellent skill to develop. A paralegal must be familiar with her boss’

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

schedule, his caseload, his clients, and his particular style in order to filter the phone calls well. She must also be thoroughly familiar with the types of new cases h

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

Combination pro

r boss may accept. This includes understanding the office’s standard procedure for inquiries he is either unable to fulfill or too busy to fulfill.

Often new assignment

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

s are derived from repeat business - a client who has used your attorney’s services in the past. A paralegal should possess basic knowledge of these return clients, incl

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

uding how to get in touch with clients by mail, phone, fax, and e-mail. Utilize your office’s file management system to keep this information handy. (If your business h

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

as no file management system, I urge you to campaign for one as soon as possible.)

One of your duties may be to recall old matter files for a returning client. Many law

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

offices utilize off-site storage for closed files. Depending on the situation, old files may contain valuable information that will assist your attorney in handling new

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

matters.

Sometimes new clients are referred by your boss’ colleagues, professional peers, friends and acquaintances. When referrals occur, make note of it so you can pr

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

Following aspects would a

epare a thank you letter from your boss. If this type of appreciation is not standard practice at your firm, discuss the benefits with your attorney. Once approved, do

dd to the challenges in developing combination products:

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

just that, automatically. Do not slack on the newly adopted nicety. Niceties often develop into more business referred your boss’ way. In any event, it shows appreciat

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

ion and is a highly professional touch.

There will also be “cold callers” who are shopping through advertising resources: phone books, the internet, television advertisi

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

ng. Here is where the true colors of a paralegal come out – having the ability to ferret which callers are just shopping for free advice over the phone. Some folks will

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

be unable to afford your attorney’s services. For those types of calls, there may be organizations to which you can refer such a caller. Know your community so that you

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

Professional from academic institutions, pharmaceutical industries, health care indust

will be able to efficiently refer callers to appropriate help.

Other “cold calls” may concern cases your boss will accept, but a potential client may need to hear some

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

confident selling tactics to win their business. Highlight your boss’ skills and track record. In the process of doing so, you will also be highlighting your own skills

.

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

. This makes hiring your boss doubly attractive because you are already establishing good rapport with the new client.

Never forget the importance of professional handl

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

Companies that provide selfless information through particip

ing of phone calls. If phone etiquette is lacking, it can actually lose business for your attorney. Support him well by handling phone calls with tiptop professionalism

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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