E-Folder - Business

1/ Write a Business Plan

The first thing that you should do when starting off on your own – is to write a business plan – this should set out the way in whic

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

h you intend to operate your business, your financial forecast and your plans for success. Get your plan checked out by your local business advisor or Chambe

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

Examples of combination products may in

r of commerce – following a well thought out business plan will help you avoid pitfalls.

2/ Get yourself an accountant or financial adviser

Having the right

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

financial support is vital – running a business is a difficult at the best of times and trying to get a handle on complex financial issues and mandatory busi

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

ness returns is nigh on impossible without the right people behind you – Don’t try and do all of this yourself.

3/ Organize yourself

Sounds simple but gener

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

Combination pro

ally when your starting a business you’ll be all things to all men from Managing director – salesman – secretary – by making sure you set time aside for all y

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

our tasks and prioritizing what’s important you will ensure that you don’t sink under a mountain of paperwork

4/ Join your local business advice center or tr

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

ade organization

Joining your local business advice center when starting out will give you two things – firstly being part of a peer group will provide the s

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

upport that you’ll need – share concerns and advice with other business people who are going through similar challenges – secondly local business groups offer

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

an excellent opportunity to network and find sales for your business

5/ Get the right legal structure

There are a variety of ways that you can setup your c

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

ompany – each has respective pro’s and con’s and this requires careful consideration – seek some advice and research your options before starting out.

6/ Cho

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

Following aspects would a

ose a business name

Ensure that your business name is unique, make sure that you cant’ be confused easily with other companies, make sure an internet domain

dd to the challenges in developing combination products:

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

name is available that matches your choice.

7/ Check out your competitors

Researching your market is vital – knowing what your competitors are offering, the

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

ir pricing – their sales techniques will help you pitch your products correctly – spend time to check out their websites – visit them at trade shows. Where y

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

ou lose sales – try and follow up by asking why – what did your competitor offer or provide that you didn’t – getting a good understanding will help you win t

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

hat next sale.

8/ Open a business bank account

Ensure that you separate your personal finances from your business finances – get the mixed up and you’ll get

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

Professional from academic institutions, pharmaceutical industries, health care indust

yourself into trouble! – make sure you set up a business bank account and has a suitable filing system to manage your business accounts.

9/ Develop a market

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

ing plan

A marketing plan is a key step for any business. Including your market research, your competitor analysis and your pricing plans – this document la

.

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

ys out your approach and gives you a plan to follow.

10/ Understand your customers

It may sound obvious but spend time with your potential clients – underst

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

Companies that provide selfless information through particip

and what their problems are and how your business and products will help solve them – understanding the needs of your customers will give you the crucial edge

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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