Useful Advices - Business

I spoke in my blog yesterday about my friend starting a new business and seeking out my business experience advice and decided today that I want to add to that post with a typical entrepreneurial

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

story regarding legal advice and their age old question; To use a lawyer or to not use a lawyer?

When we start a new small business we generally have most of our financial resources already in th

; 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 business. Therefore, when 'trivial' details like business contracts need to be signed a lawyers opinion and advice is generally sacrificed. I have signed many multi-million dollar contracts over

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

the years and live by the opinion that every contract can be broken, it's just a matter of weighing the risks against the benefits as well as the level of probability (high or low) if and what da

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

mages would be incurred under various scenarios. So seeking out a legal opinion isn't something I would do in all cases. However, if you see high risk and many pitfalls in a contract then you must

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

Combination pro

seek a third opinion and generally a lawyer is your best and safest bet. But remember that not all lawyers are experts in every aspect of business.

A lawyer (not all lawyers) will tell you yes 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

can help you with your contract evaluation and even negotiation but is really only interested in the hourly fee they can collect from you during the soon to be lengthy and protracted process. You

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

r proper due diligence may become your lawyers next Goose that lays the Golden Eggs.

As is the case in most professions, the legal profession has specialists. Using a specialist in the evaluation

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

of your business contract may save you money in the long run. Also, remember that theirs is a legal opinion and not necessarily a business opinion and should be only one of many opinions you rece

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

ive. For example; you may have an opinion from your financial advisor, your accountant, your operations head, your sales department, etc. At some point the buck stops with you and you have to make

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

a go or no go decision. And on occasion, it may be against the advice of your lawyer. That's just business. Anyway, back to how a specialist can save you money, a specialist who has seen similar

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

Following aspects would a

contracts and clauses before can speak from experience and get right to the potential problem areas right away. They can also advise that the contract is a standard contract for this industry and

dd to the challenges in developing combination products:

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

advise of it's expressed and implied intent and then leave you to decide to go or no go on the execution of the agreement. An example of this is franchise agreements.

A typical franchisor - franc

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

hisee agreement is written to protect the franchisor. That is to say, to protect the existing franchisees and of course their investment. If you are considering a franchise then you want an agreem

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

ent to be written this way. To protect you as a new franchisee. In fact, any franchisor who is prepared to re-write their agreement for you is really saying, no protection for you, we are only int

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

erested in your money. If you experience that kind of accommodating franchisor you should turn and run away as fast as you can.

They are after your wallet and you are about to be mugged. In this

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

Professional from academic institutions, pharmaceutical industries, health care indust

franchise example, if you are speaking to a contract lawyer but not someone who specializes in franchise law then you will get a lawyer who will charge you by the hour to get the franchisor to re-

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

write the agreement to be more fair to you and if the good franchisor is not prepared to re-write their agreement then you are just throwing your money to the lawyer in the form of a golden egg. A

.

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

specialist in franchise law will recognize a standard franchise agreement, highlight the meaning of particular clauses to you and then generally say, it's a standard franchise agreement, do you w

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

Companies that provide selfless information through particip

ant to do the business or not? If you do then sign the agreement. In this scenario, the legal specialist just saved you a great deal of money.

Don't let the lawyers profit from your due diligence

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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Most companies can benefit from going to exhibitions every once in awhile, but if you aren't a creative person, it can be difficult to make an interesting booth where people will want to stop.

These days we're meeting a lot of people with a particularly frustrating problem: their business is in a constant state of crisis. We're talking about when making the numbers always turns into a frantic sprint to the finish - and you have no real time to recover before you're in the middle of the next sprint. What can you do about this?

Internet marketer looking for sales? Stop focusing on sales. Start focusing on people.

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Useful Advices - Lawyers Profit From Our Due Dilligence

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