Answers - Legal

When a new car rolls off the assembly line, every part on it has been checked, double-checked and checked again to make sure it meets the exact specifications and toleran

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

ces established by the automotive engineers who designed it. Car manufacturers know that in order to sell more cars, and remain profitable and competitive, they have to

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

Examples of combination products may in

keep their quality up.

Now, measuring quality on your legal team isn’t quite as straightforward or engineering-oriented as measuring the specs and tolerances on engines

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

and transmissions. After all, the legal profession is a service, not a product business. And the quality of service businesses is sometimes difficult to measure accurate

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

ly.

The legal profession has always measured its value based on billable hours, rather than bottom-line results, and this also makes the quality of legal services diffic

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

Combination pro

ult to determine. But even though it’s more difficult to determine – more ambiguous and subjective – art rather than science – nevertheless, it can be done.

So how do y

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

ou evaluate the quality of your legal team? It’s not much different than those automotive engineers who sit down and design plans for how they want their cars to look wh

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

en they finally roll off the assembly line.

You start by outlining the results or outcomes that you hope to achieve from a particular legal engagement, and then clearly

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

communicating those outcomes to your legal team. You want good value for your money, so by defining your expectations and outcomes beforehand, you let your team know what

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

you think is important and valuable in a legal engagement. So define what a successful engagement would look like to you. What results are you hoping to achieve? What a

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

re your expectations regarding your legal team? Try to be as specific as possible.

Rather than thinking in terms of win or lose, you may want to consider a range of poss

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

Following aspects would a

ible outcomes, from best to worst case. Once you’ve decided on the results you’re looking for, break down the engagement by tasks, and try to estimate the number of hour

dd to the challenges in developing combination products:

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

s required for each. You may want to assign areas of task accountability to specific members of the legal team.

On larger projects, you’ll want to set milestones, either

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

in percentage of hours billed or engagement tasks completed, where you can measure ongoing engagement progress. Schedule periodic progress reports and reviews and build

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

them into your engagement contract. When reviewing engagement progress, you’ll need to note any variances from original estimates and expectations and update your progre

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

ss reports as needed to reflect any changes.

Review all monthly billing statements for accuracy, and you may want to enlist the help of an outside firm that specializes

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

Professional from academic institutions, pharmaceutical industries, health care indust

in managing legal financial reporting to assist you with all of the paperwork.

You should also insist on good customer service including:

 Timely notification o

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

f any engagement status changes
 Discussion of fees and scope of work before engagement is awarded
 Return phone calls and emails in a timely ma

.

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

nner
 Accurate and timely monthly statements
 Specifying lawyers that you want handling your case

Follow these guidelines and you’ll not only h

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

Companies that provide selfless information through particip

ave a cost-effective, low-maintenance and smooth-running legal engagement, but you’ll also have a high-powered legal team that’s firing on all cylinders for years to come

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.answers.org.ua/article/127686/answers-Measuring-the-Quality-of-Your-Legal-Team.html">Measuring the Quality of Your Legal Team</a>

BB link (for phorums):
[url=http://www.answers.org.ua/article/127686/answers-Measuring-the-Quality-of-Your-Legal-Team.html]Measuring the Quality of Your Legal Team[/url]

Have you heard the latest? Google is giving away millions of dollars in free ads! Or so many people would like you to believe. In our competitive world of internet marketing, there will always be people who think they can outsmart a system, especially Google Adwords. And with that said, there will always be people who believe those people and will pay good money to get the information.

Invoice factoring is simple and alleviates the liable party of the debt for less than the full amount.

A whole life insurance policy is a good long term investment vehicle if you are not planning to benefit from it yourself, unless you know that you will live until you are 100 years old. Whole life insurance policies terminate when you reach your 100th birthday, after which you will receive cash equivalent of the policy. But a whole insurance policy is meant to cover your hospitalization and medicine expenses caused by illnesses, accidents, or your death. You may borrow from it, though, and the loan may be paid for by your premium. You may also wish to cancel it and obtain the cash value of your payments.

Tags

Links

Answers - Measuring the Quality of Your Legal Team

Related Articles: