Cases - Business

So you want to start a website that will charge the visitors for membership through their credit cards? Such a site can not run unles

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

s you have a high risk merchant account. Here are some questions frequently asked by people who want to start accepting credit paymen

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

Examples of combination products may in

s online.

Q. What are high risk merchant accounts?

A. High risk merchant account is a type of merchant account that is more incline

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

to encounter fraud. This is due to the fact that people who have such accounts run businesses that do not have any physical represen

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

ation under the jurisdiction of the law.

Most of the time, people who have high risk merchant accounts run their business online. An

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

Combination pro

with the number of computer hackers lurking around the net, they are not safe from people who could get into their websites without

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

having to pay. Due to this, account providers who accept such clients will charge you with high rates that could hinder the growth of

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

your business. Examples of these accounts are adult websites, online casinos, and pharmaceutical merchants.

Q. How do I get such an

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

ccount?

A. The process of obtaining such an account could be a long and frustrating process due to the amount of paperwork you need

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

o go through. Due to its nature of being "high risk," providers will always think twice before they even grant their applicants such

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

equests. Fortunately, there are organizations that are willing to help you simplify this very complicated process. By helping you est

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

Following aspects would a

ablish accounts with major credit card companies, these partners can help lighten the burden of acquiring these accounts. In addition

dd to the challenges in developing combination products:

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

these groups could also help you set up a payment process that is integrated into your account.

Q. Do I need to pay a large amount

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

f money before I can attain an account?

A. Unfortunately, yes. Because it is high risk, providers may charge you high fees. But ther

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

are some providers who won't require you to pay an expensive application fee, but beware because they may charge you with high rates

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

to maintain them.

Q. How do I get paid?

A. Each transaction will first go through the providers. Here, they settle the payments you

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

Professional from academic institutions, pharmaceutical industries, health care indust

have received with the credit card companies they are associated with. The time it takes for you to receive your funds varies among

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

roviders, but generally this process takes around three days to a week.

Q. How long does it take for me to get an account?

A. Depen

.

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

ing on the information you give to your providers, the result of your application may come in as fast as one day or in a month. If yo

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

Companies that provide selfless information through particip

do not wish to wait a long time to get your account, then be sure to provide complete and sufficient information in your application

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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