Useful Advices - Business

Business Owners tend to identify themselves with their business. They show pride in the name, the function and the growth of their business. After all, it’s their ‘baby’. But there are three important reasons why your busi

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

ness and you should not be so closely identified: (1) Protection, (2) Privacy and (3) Capital Growth.

Protection is Most Important.

Millions of business owners make a spl

; 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 about letting the world know that they and the business are essentially ‘one and the same’. This is often seen in the number of ‘Sole Proprietors’ out there who set up shop with a business checking account, some busines

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

s cards and a fictitious business name (‘DBA’ or ‘doing business as’) filing with their County clerk. The risk, of course, in being a Sole Proprietor is that you and the business are legally ‘one and the same’ and thus all

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

of your personal assets are at risk in the event of a business reversal or a lawsuit.By protecting your business inside of a legal entity, you are taking a step in the right direction to separate you and the identity of th

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

Combination pro

business. Corporations and Limited Liability Companies are two much better ways to organize your business. For years, corporations have been ‘top dog’ but now the Limited Liability Company (‘LLC’) is emerging as the prefe

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

rred entity of choice by business owners and investors everywhere, due to its simplicity, flexibility, protection and tax advantages. By using a company (whether corporation or LLC), you are not the business (for liability

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

risks) and it is not you. The business can and should stand on its own – so that your personal assets are not at risk. Today there are more LLCs being formed than corporations. The emerging 'Series LLC' represents the late

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

st evolution in company formation. The series LLC helps to keep legal and tax accounting costs down but provides for separate business enterprises operating within the same LLC 'mother ship'. Each series or cell can have i

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

s own business operations, its own liabilities, its own blance sheet. And yet, at the end of the year, all of the cells or series can be conslidated into a single tax return. Very Nice.

Privacy Should Not B

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

OverlookedIdentity theft is the fastest growing crime there is in America. A thief can use different methods, but their goal is always the same – to profit and benefit at your expense, using your identi

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

Following aspects would a

ty. One of the best steps you can take to reduce your risk and increase your personal financial privacy is to utilize an entity such as an LLC.The name of the LLC or corporation should be different than yours. It can have

dd to the challenges in developing combination products:

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

ts own Tax ID number, its own business credit profile and credit rating, its own credit and debit cards, its own vehicles and equipment, and it can separately own both real estate and other property from you. The entity an

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

d you should have separate bank accounts and separate financial identities. The less you ‘co-mingle’ personal assets and business assets the better.

Obtaining Business Credit

In the earl

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

formation and start-up phases of most business, it seems as though every vendor and every provider wants you personally to sign for and be responsible for any business-related purchases, leases or credit. This can put tre

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

endous burden on your personal credit – and in fact if used in the wrong way, it can seriously damage your personal credit by doing so. Building credibility for your business should mean building a business credit rating a

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd credit profile that stands alone, separate from your own personal credit. Most small business owners simply take the ‘default decision’ that they must personally pledge payment of business-related leases, purchases or o

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

her financial obligations. But this does not have to limit you.

There is another way. By using a corporation or LLC instead of an unprotected sole proprietorship, you can begin establishing a separate business identity. T

.

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

hat business identity can in fact have its own credit profile and credit rating, and this will serve to help take the pressure off of your own credit. By doing so, this frees up your own personal credit so it’s not carryin

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

Companies that provide selfless information through particip

the burden of your credit needs as well as your business credit needs. Every journey begins with a single step. To get started, see www.OneMinuteTaxCoach.com

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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Useful Advices - 3 Reasons Why Your Business Should Not Be You

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