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For fresh graduates or for employees who want to start their own businesses, one of the hardest things to do is to g

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

et the capital that they need to do so. This is because most of the traditional sources of loans or funding are appr

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

Examples of combination products may in

hensive in providing funds for start-up businesses. Given this, most of them opt to shelve their business idea until

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

they get the money they need. Some opt to sell equity, and some of them borrow the money from relatives and friends

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

However, people who want to go into business for themselves need not wait until they get the money from these sourc

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

Combination pro

s because there is a good source of capital that they can tap into. All they need is a good idea and a strong busine

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

ss plan. This source is an angel investor.

What are angel investors?

Angel investors are either individuals or com

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

anies who put in money into startup businesses. However, their role in the business is not limited to being an inves

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

tor because angel investors take an active role in the management of the business as a means of protecting their inv

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

stment, which is why angel investors are usually businessmen themselves who are astute in handling businesses. Ther

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

are three ways by which an angel investor can provide funds for a business. One of these is by providing money thro

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

Following aspects would a

ugh a promissory note or a loan, which can be converted into an equity position in the company after the launching p

dd to the challenges in developing combination products:

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

ase of the company. Usually, the investor would take about 15 to 30 percent equity in the company, which is enough t

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

o gain a set in the board.

The second way angel investors provide funds is through a cumulative convertible preferr

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

d stock option, wherein the investor defers the dividend payments he would receive from his stock, while he holds a

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

eat in the board. The third way is for an investor to get an equity position right away when they put in their inve

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

Professional from academic institutions, pharmaceutical industries, health care indust

stment. In this set-up, they have an option to bring in one or two of his associates to help in the management of th

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

business.

One good source of money that aspiring entrepreneurs can tap is an angel investor, which can provide the

.

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

m with the capital they need to launch their business. The good news is that apart from being able to get the money

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

Companies that provide selfless information through particip

hey need from these investors, they can also gain a number of benefits from the managerial expertise of the 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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