Main Subject - Business

The type of business structure you organize for your new enterprise is greatly determined by your personality, realities, needs and experience. Millions of people in the United States never enter into any type of formal business structure. This includes the bulk of the black or unde

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

rground economy.

It is estimated that the underground economy consists of about 10% of all commercial activity in the United States. This includes legal and illegal activities. A kid cutting your grass for $20 is technically working black. The handyman that repairs your patio for c

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

Examples of combination products may in

sh might be working black. Drug dealers are definitely kingpins of the underground economy.

Entrepreneurs should not want to work black, but should seek to be totally transparent for many reasons. The reason a person typically seeks to become an entrepreneur is to maximize the oppo

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

tunity our capitalist system offers each person willing to try. This means playing by the rules, competing and pursuing success utilizing every available legal tool. The opportunity to sell a successful entrepreneurial business is almost zero without complete books, records and tax

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

eturns, typically details that underground business works hard to avoid.

I recommend any new entrepreneur seek consultation with an attorney familiar with the laws and regulations of the state, county, city or township of your residence. Even if you are planning to run your enterpr

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

Combination pro

se as a sole proprietorship, there are local zoning laws, restrictions on business activity, public announcement requirements, DBA (Doing Business As), fictitious name ordinances, etc. Do not try to avoid the pesky forms and filings required in most localities. If compliance is a hu

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

dle for you, then success prospects for you as an entrepreneur are probably slim.

Your investment in the attorney consultation will pay for itself. You can go online, or visit the business section of the local bookstore and find just enough information to get yourself in trouble in

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

these areas. Occasionally, I meet an entrepreneur that did not consult professionals, and has everything in order. This is very rare. More often, I meet shortsighted dreamers trying to cut a corner and save a few dollars. Professional help will save you time, money and mistakes.

He

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

e are the most common business structures that entrepreneurs have access to when formalizing their new venture.

Sole Proprietorship

This is the most commonly utilized structure for new, small, startup business ventures. Essentially, the proprietor, you, the entrepreneur, announces

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

that you are working alone. The sole proprietor accounts for all income from sales as personal income and is responsible for all debts incurred by the enterprise. Personal and business funds are often commingled in this structure and need to be identifiable for tax purposes. There i

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

no formal corporate entity, but you must adhere to all local laws and statutes. A Federal Identification Number is not needed (use Social Security Number) when filing taxes.

Partnership

When two or more people decide to enter a partnership, they basically agree to enter a form of

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

Following aspects would a

marriage. We all know that marriages can get messy. Partners must minimize any possibility for a messy divorce by creating a partnership agreement that details what each partner brings to the opportunity (investment, sweat equity, intellectual property, etc.). Also, the partners re

dd to the challenges in developing combination products:

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

ponsibilities (silent, working, sales, marketing, production, etc.), and an agreed split of income, profits and harvest, as well as liabilities and losses.

I like, and often recommend, a partnership for young entrepreneurs with limited, narrow experience. Operations experience ofte

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

does not translate to sales and marketing for instance. The only imperative is that there are no surprises after the enterprise succeeds, or fails. This when a cloudy division of liabilities or profits often becomes problematic.

Limited Liability Corporation (LLC)

Again, there ar

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

“do it yourself” methods of creating LLC’s. Use an attorney. I am no friend or fan of the legal profession. I am not a lawyer, either. I just know from experience that this is difficult: and often a contentious area of law that requires expertise.

An LLC limits the owner’s exposur

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

to some losses. The LLC also enables the owner to treat income beneficially for tax purposes. Professional legal and accounting assistance is really important in establishing the LLC in a proper legal format.

Corporation

The Corporation offers the most comprehensive protection fo

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

Professional from academic institutions, pharmaceutical industries, health care indust

the owners. Losses accrue to the Corporation, in most cases. The Corporation assumes the role of a person, even though abstract. A Corporation requires the filing of Articles of Incorporation in a state. Consult an attorney for advice on which state to file this document. Nevada of

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

ers secrecy. Delaware is most popular for large corporations. Each state has different fees and requirements. Get good help!

The Incorporation requires a fair amount of housekeeping. This includes appointing a board of directors, keeping meeting minutes, issuance of stock, etc. Man

.

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

startups convert to corporate status after achieving some amount of success.

There are other intricate options, trusts and arcane structures available. However, for 99.9% of all entrepreneurs the four discussed here offer the best vehicles for properly structuring a new business.

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

Companies that provide selfless information through particip

pproach each with the goal of maximizing your income and minimizing your time commitment to housekeeping the entity you choose. Remember: in order to be successful as an entrepreneur will require every scintilla of your thought, work and creativity to be concentrated on your project

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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A simple definition for accounting may be acceptable to an individual. That accounting definition however may not be as clear with regard to an ongoing business enterprise.

Do you need fundraising ideas? Well, you need to know that it is MORE than just ideas. On the surface, finding fundraising ideas is easy. Get together a group of co-workers or co-volunteers into a brainstorming session, and you will likely get a list of ideas ranging from jumble sales to door-to-door selling to a direct mail campaign.

What gives? You have a stunning website with an audio intro and newsletter sign-up, but no one is buying from you. Maybe you’re wasting your time on the wrong target market or maybe you are sending the wrong message to your potential customers/clients.

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