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If you've researched your market, thought over the pros and cons of a home-based business, and decided to go ahead, it's time to put together a business plan.

Developing a business pla

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

n forces you to take an objective and critical look at your business idea. Even more, the finished product is a tool that will help move your business toward success.

A business plan s

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

Examples of combination products may in

ould be neat, written clearly, and should include several things. The cover page should list the business name, address, mailing address, telephone number and the name(s) of the owner(s). Ident

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

fy your primary goals and objectives. Next, give an accurate and concise description of the business:

-What is the principal activity? Be specific. Give product or service description

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

s.

-How will the business be started?

-Why will it succeed? Promote your idea. Use your market research.

-What skills and experience do you bring to the business?

Mark

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

Combination pro

ting is the core of your business. Carefully think about the following questions, then include your marketing strategy in the business plan:

-Can you market your business from home?

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

>

-Who and what is your market?

-What pricing/sales terms are you planning?

-How will you be competitive?

Money fuels all businesses. With a little planning, you'll find th

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

at you can avoid most financial difficulties. When drawing up a financial plan, don't worry about using estimates. The process of thinking through these questions helps develop your business sk

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

lls and leads to solid financial planning.

Start-up costs: To estimate your start-up costs, include all initial expenses such as fees, licenses, permits, telephone deposit, tools, off

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

ce equipment and promotional expenses. Business experts say you should not expect a profit for the first eight to 10 months, so be sure to give yourself enough cushion.

Projecting oper

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

ting expenses: Include salaries, utilities, office supplies, loan payments, taxes, legal services and insurance premiums. Don't forget to include your normal living expenses.

Projectin

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

Following aspects would a

g income: It is essential that you know how to estimate your sales on a daily and monthly basis. From the sales estimates, you can develop projected income statements, break-even points and cas

dd to the challenges in developing combination products:

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

-flow statements. Use your marketing research to estimate initial sales volume.

Cash flow: Working capital, not profits, pays your bills. Even though your assets may look great on the

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

alance sheet, if your cash is tied up in receivables or equipment, your business is technically insolvent - in other words, you're broke.

Make a list of all anticipated expenses and pr

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

ojected income for each week and month. If you see a cash-flow crisis developing, cut back on everything but the necessities.

Conclusion

Persuasion is the mis

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

ing puzzle piece that will crack the code to dramatically increase your income, improve your relationships, and help you get what you want, when you want, and win friends for life. Ask yourself

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

Professional from academic institutions, pharmaceutical industries, health care indust

how much money and income you have lost because of your inability to persuade and influence. Think about it. Sure you've seen some success, but think of the times you couldn't get it done. Has

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

there ever been a time when you did not get your point across? Were you unable to convince someone to do something? Have you reached your full potential? Are you able to motivate yourself and

.

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

others to achieve more and accomplish their goals? What about your relationships? Imagine being able to overcome objections before they happen, know what your prospect is thinking and feeling, f

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

Companies that provide selfless information through particip

el more confident in your ability to persuade. Professional success, personal happiness, leadership potential, and income depend on the ability to persuade, influence, and motivate others.

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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