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Writing a business plan can be intimidating. It is however a necessary step towards earning a business loan for the launch or expansion of a professional practice or

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

small to mid size business. Gaining an understanding about the expectations that the bank, government or other type of investor have about the contents of your busi

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

Examples of combination products may in

ness plan can help you to get started.

The following is a comprehensive list of the basic components of a business plan focused on securing financing:

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

xecutive summary

Core strengths and point of differenc

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

e business offers

Projected sales and profitability

Details with regards to financing request

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

Combination pro
>

A mission statement is a single sentence that communicates the core values of the practice or business. It establishes the reason for being for the organiz

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

tion. A vision statement is a single statement that communicates business goals for the next 3-5 years in terms of the most appropriate benchmarks whether they are m

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

arket share, reputation or financial.

Human resources:
The objectives of this section of your business plan are to present the strengths of the core

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

management team as well as the projected costs of the employees:

Biography of the founding team members and relevance

Staffing requirements

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

Core strategies to manage team

Business environment:
A discussion on the business environment in your business plan demonstrates ex

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

pertise as well as comprehension of the changing dynamics of the marketplace:

Industry overview

Positioning statement

An analysis of st

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

Following aspects would a

rengths, weaknesses, opportunities and threats
Competitive grid

Barriers to entry

Marketing:
A marketing plan is re

dd to the challenges in developing combination products:

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

evant to a business plan whether it accounts for traditional or non-traditional promotional types of activities:

Consumer insight

Description of

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

service, promotional activity, location, fees
Core strategies to market practice

Operations:
Outlining the operations of you

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

r business may account for standard, special or proprietary processes:

Core strategies to operate practice

Finance:
Financia

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

statements enclosed within your business plan need to be achievable rather than overly optimistic:

3 year detailed sales projection

3 year deta

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

Professional from academic institutions, pharmaceutical industries, health care indust

iled profit and loss statement

Risks & conclusion:
Your business plan should identify which risks you consider to be inherent to the b

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

usiness and how you expect to handle them. It should detail the core strategies you plan to employ in order to mitigate risks.

Remember that the objective of

.

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

your business plan is to communicate why you are a good candidate for this business loan. Ideally your business plan will have demonstrated expertise accompanied by

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

Companies that provide selfless information through particip

achievable sales projections, key ingredients to developing the perception that your business is a low risk investment to a bank, government or other type of investor

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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E-Folder - A Business Plan Can Secure Financing for a Professional Practice or Small to Mid Size Business

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