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The paralegal profession is currently experiencing a great deal of growth and prosperity. With the ave

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

rage USA annual salary averaging around $34,000 for local and state work, nearly double that for Feder

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

Examples of combination products may in

al Government work, and much more in the private sector, it’s no wonder this career field is growing.

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

Let’s take a look at a few reasons why a career as a paralegal is so rewarding.

Challenging Work

Att

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

orneys pass much of their workload along to paralegals, also known as legal assistants. Note that para

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

Combination pro

legals may not perform all attorney tasks, including setting legal fees, giving out legal advice, and

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

presenting court cases.

Case preparation is part of the workload. Paralegals help lawyers with backgr

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

und information and research, legal history, case studies, fact-finding investigations, document prepa

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

ration and analysis, plea documents, folder, record and file handling. The work they perform is often

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

involved with hearings, trials, closing comments, and also corporate functions.

Jobs are available f

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

or paralegals in many types of companies and organizations. They work with employee benefits, labor la

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

Following aspects would a

w, criminal law, corporate law, government (at all levels), real estate and bankruptcy. And you’ll fin

dd to the challenges in developing combination products:

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

d them working in personal injury law and litigation as well.

Career Tidbits

The following list incl

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

udes some interesting information about this career field according to the U.S. Department of Labor Bu

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

eau of Labor Statistics Occupational Outlook Handbook.

- Paralegals most often work year round, altho

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

ugh some temporary work is available. Although 40 hours is average, heavy workloads are a possibility.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Work isn’t always at the office; paralegals need to work in libraries and often travel in order to ga

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

ther relevant information.

- In 2004, there were 224,000 paralegal jobs, with private practices emplo

.

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

ying roughly 7 out of 10 of them.

- Job opportunities for paralegals are projected to increase at a f

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

Companies that provide selfless information through particip

aster than average rate through 2014.

There’s no better time to check into being a paralegal than now

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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