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Main Subject - How To Write A Business Plan And Make It Your Blueprint For Success
Why write a business plan? There are several reasons why you might want to write a business plan.
1. It is a tool for obtaining financing.
2. It will help unite venture partners in
1. It is a tool for obtaining financing.
2. It will help unite venture partners in
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
a common goal.
3. It can serve as a feasibility study.
4. It will serve as a goal and blueprint for your new business.
Of all of the purposes listed, the last one is the
3. It can serve as a feasibility study.
4. It will serve as a goal and blueprint for your new business.
Of all of the purposes listed, the last one is the
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ost important. According to the Small Business Administration, 95% of all businesses started, fail within the first 5 years. One of the main reasons for failure is a lack of direction or go
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
als. A business plan will give you that direction or goal, if it is used properly.
The Foundation For Writing A Business Plan
There are several things you need t
The Foundation For Writing A Business Plan
There are several things you need t
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
consider before beginning to write:
1. Consider whom you are writing the plan for.
2. Have a firm idea of what product or service you are offering.
3. Do market research to de
1. Consider whom you are writing the plan for.
2. Have a firm idea of what product or service you are offering.
3. Do market research to de
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
termine the demand for your product or service. Learn who your potential customers are.
4. Decide how you are going to sell your product or service to your potential customers. It does
4. Decide how you are going to sell your product or service to your potential customers. It does
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
not matter how good your product is unless you are able to sell it for a profit.
5. Determine where you are going to get the money necessary to start your business. You must have enough
5. Determine where you are going to get the money necessary to start your business. You must have enough
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
financial reserves to pay the expenses until you pass the breakeven point and start making a profit.
Writing Your Business Plan
After you have finished your rese
Writing Your Business Plan
After you have finished your rese
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
rch and background preparation, it is time to list the reasons why your business will succeed. You are essentially writing a report to yourself. Your report must address all the areas that
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
are obstacles to business success. Your business plan must be able to convince a reasonable person that you can succeed. It is also your goals for success. Without a goal, your aim is haph
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
zard and prone to failure.
Business Plan Outline
The following is an outline suggested by the US Small Business Administration:
Elements of a Business Plan
D. Breakeven analysis
E. Pro-forma income projections (profit & loss statements)
Three-year summary
Detail by month, first year
Detail by quarters, second and th
Business Plan Outline
The following is an outline suggested by the US Small Business Administration:
Elements of a Business Plan
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
r>
1. Cover sheet
2. Statement of purpose
3. Table of contents
I. The Business
A. Description of business
B. Marketing
C. Competition
D. Ope
2. Statement of purpose
3. Table of contents
I. The Business
A. Description of business
B. Marketing
C. Competition
D. Ope
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ating procedures
E. Personnel
F. Business insurance
II. Financial Data
A. Loan applications
B. Capital equipment and supply list
C. Balance sheet
E. Personnel
F. Business insurance
II. Financial Data
A. Loan applications
B. Capital equipment and supply list
C. Balance sheet
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
D. Breakeven analysis
E. Pro-forma income projections (profit & loss statements)
Three-year summary
Detail by month, first year
Detail by quarters, second and th
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
rd years
Assumptions upon which projections were based
F. Pro-forma cash flow
III. Supporting Documents
Tax returns of principals for last three years Personal
Assumptions upon which projections were based
F. Pro-forma cash flow
III. Supporting Documents
Tax returns of principals for last three years Personal
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
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
financial
statement (all banks have these forms)
For franchised businesses, a copy of franchise contract and all
supporting documents provided by the franchiser
Copy
statement (all banks have these forms)
For franchised businesses, a copy of franchise contract and all
supporting documents provided by the franchiser
Copy
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
f proposed lease or purchase agreement for building space
Copy of licenses and other legal documents
Copy of resumes of all principals
Copies of letters of intent from suppli
Copy of licenses and other legal documents
Copy of resumes of all principals
Copies of letters of intent from suppli
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ers, etc.
Summary
The suggested research is the basis for writing your business plan. The business plan you are writing will be the blueprint for your new busin
Summary
The suggested research is the basis for writing your business plan. The business plan you are writing will be the blueprint for your new busin
.
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
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
ss. Consider what a house would be like if the builder did not use a blueprint. You want your business to be well built like the house you live in. Just as a carefully planned house will l
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ast many years into the future, you want no less for your business. If you do not take the time necessary to develop your business plan, then you still have a plan. It is a plan for failure
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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