Write You - Finance

You have been in business for several years and you have been handling the finances for your business. One day you get tired of managing the money, receipts and all the paperwork to prepare

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

for taxes. You begin to think to yourself who you can contact, what steps you can take! You put the thought of your mind and continue running your business. A week later you are driving do

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

Examples of combination products may in

n the road and you hear a thirty second commercial on the radio. The voice says, “Have you been managing your business finances for several years and now you have grown tired? Now is your c

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

ance to contact Journey to Wholeness. They will teach you about building a financial team. Contact them at www.journeytowholeness.net” Then it returns to music.

You begin thinking to yours

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

lf – what is a financial team? Who makes up a business financial team and can there be a downside to a financial team? When building a financial team the following are important:

1) Bookk

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

Combination pro

eper

2) Accountant

3) Personal Banker

4) Financial Planner

The role of the bookkeeper is to handle your monthly bank statements and reconciling your account. You would give this perso

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

n all of your receipts so that they have all the necessary paperwork to give you the summary of your account. The bookkeeper can generate reports based on your monthly statements. The bookk

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

eper can advise you on sales tax and a sales tax license if you need that for your business

Next is the accountant. The accountant would do your taxes at the end of the year with the vari

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

us statements from the bookkeeper. This should be a fairly easy connection based on who your bookkeeper is. The accountant can advise you of all the deductions you should be taking for your

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

business. I have often talked to business owners that did not have an accountant and invariably did not deduct all that was allowed.

Personal banker is the person that you would discuss ov

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

r different lines of credit and financial tools you might need for personal and business. You could discuss with the personal banker a business account, setting up the account and even ha

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

Following aspects would a

ving a business line of credit.

Financial planner is the person that will help you with long term goals such as life insurance, disability and retirement planning. Even if you do not talk

dd to the challenges in developing combination products:

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

o this person initially, make sure you eventually take the time to talk to a financial planner and discuss long-term goals.

The bookkeeper is not necessary if you are skilled and knowledge

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

ble in managing your personal finances. Pitfalls to not having personal financial team working for you is that you do not accomplish financially what you would like to. You end up in debt a

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

d do not know how to remove the debt as well as get back on your feet. When you do not set goals, you have nothing to work towards.

A Financial Team is outside looking in with an unbiased

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

pinion. That can help you achieve goals and dreams for you and your family. Maybe after reading this you are asking yourself, do you need a financial coach? You might because they can provi

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

Professional from academic institutions, pharmaceutical industries, health care indust

de one-on-one coaching or counseling based on where you are. They also could connect you to others member for your financial team.

Too many people on the team can spoil it if they are not

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

n agreement about what needs to be done. If you are in the beginning phase of building a financial team, I recommend starting out with the bookkeeper and accountant. Either one of them if n

.

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

t both of them should be able to recommend a financial planner. You should already know your personal banker.

Take the time today to assess where you are and if you need a financial team.

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

Companies that provide selfless information through particip

The time a financial team could save you and teach you could mean the difference between success and failure in your business. It is my hope that you would prepare your business for success

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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