Subjects - Business

Risk management is an important element in managing your business. You have a wonderful plan for your business, s

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

o you want to protect it against risks.

Qualified Advisors Help You
Protect Your Business

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

Examples of combination products may in

nter>
It is essential that you find qualified advisors to help you with the legal aspects of protecting your

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

business. Interview your potential advisors to find a fit in personality, objectives, and business philosophy. Tr

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

st your gut feeling; you haven't become successful in your business by ignoring your intuition!

Here are the fou

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

Combination pro

types of qualified advisors who can help you with business management and risk management concerns:

Acc

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

ountant

This is probably the most important advisor you can have. An accountant will help you get

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

your business off on the right footing. Not only will he/she set up your books, but you'll also receive help with

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

management, tax reporting, and strategic planning.

Insurance Agent
Insurance is a complica

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

ed issue. Lawsuits abound in our society and virtually all businesses are at risk. You may also be liable for act

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

of employees or people under contract to you. "Better safe than sorry" is an old adage that applies to insurance

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

Following aspects would a

coverage with your business. Your liability may extend to your personal finances, also, depending on the type of

dd to the challenges in developing combination products:

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

business you chose.

Banker
There may be a time when you need outside capital for your busi

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

ess. You might need new equipment, a new computer/cash register, money for expansion, or cash flow management. If

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

you have a relationship with a banker when you start your business, he/she will know about your business when you

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

need that extra cash or extra help.

Attorney
You need an attorney who specializes in busin

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

Professional from academic institutions, pharmaceutical industries, health care indust

ess issues. The best way to find an attorney is to ask your accountant or banker for a referral. Business law is

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

complex world, so it's important to start out right.

The cost of finding advisors may seem high at first, but s

.

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

ould be included in the start-up costs of your business. Your advisors will save you money in the long run. You m

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

Companies that provide selfless information through particip

y find that your accountant can give you the advice you need to get started. Remember, "Better safe than sorry.

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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CPA is short for Certified Public Accountant. There are many CPA firms that are some of the most reputed and well-established companies in America. A CPA firm performs many functions and has many specialties including auditing and attestation, accounting systems, taxation, business valuation, management consulting, forensic accounting, information systems consulting and information systems auditing. This is why they are so important to successful businesses and entrepreneurs. These businesses and individuals count of a CPA firm to keep them financially on track and ahead of the game.

One of the best administrative professionals, and most productive people I know, is my mother. She is 78 years old and still works full-time as the personal assistant to the CEO of a bank! (I come from great genes – it makes me very optimistic about my long-term future!) One of her secrets to productivity is what is often called “a tickler file.”...Everything Old is New Again!

Sending a thank you letter or thank you email after a job interview is a great way to follow up with a hiring manager and to express your interest in a position. There is another important reason why sending a thank you note can pay dividends.

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