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Like many people, you may feel that you prefer the low maintenance and modern comforts that come with new build prop

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

erty but equally do not want to be on a development where all the houses are the same.

There are two options for yo

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

Examples of combination products may in

u-

1) Buy a plot of land, get an architect and do your own thing

2) Buy a plot of land with planning permission an

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

developers ready to build a home to suit you.

1) DO YOUR OWN THING

This first option is the most time consuming a

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

nd requires the most effort from your part - but should result in an individual looking house built to your spec. Th

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

Combination pro

build cost will generally be higher than for option 2 but you will save by buying a plot without planning permissio

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

n and reap the subsequent financial rewards once planning is granted.

There is however no guarantee that you will b

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

granted planning permission or it may in fact take a number of years. If it is granted, you then have 2 years in wh

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

ich to begin your project - but should you wait beyond this period to begin construction the permission granted will

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

be null and void and you will have to begin the process all over again.

Individual plots of land with planning alre

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

ady granted are rare and also come at a premium. It is prudent when looking for these plots that you ensure that the

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

Following aspects would a

re are water and electricity connections nearby as digging trenches for laying pipes and cables over long distances

dd to the challenges in developing combination products:

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

an get very costly.

2) WORK WITH DEVELOPERS

Your second option is to buy a plot of land within a small "lotissemen

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

t" with planning permission already granted and developers ready to build and totally manage the entire project.

Yo

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

may be given a standard choice of several houses for each development and a lot plan for you to choose your plot. 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

his is probably the cheapest option.

You also have the choice of changing the layout of the house to suit your pers

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

Professional from academic institutions, pharmaceutical industries, health care indust

nal requirements/taste. However, the more deviations from the original plan the higher the costs in general.

Altern

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

atively, you can buy just the plot and design a house from scratch with the developers who will be able to guide you

.

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

and design something that is totally your own. This last option is the most expensive as it is similar to option 1.

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

Companies that provide selfless information through particip

However, as everything is done "in-house" the process is far simpler for you, far less time consuming and less risky

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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Education verification is an important part of your general employee background check. If you believe that this has lesser importance than a criminal background check, consider the case of Laura Callahan who resigned as Director of the Department of Homeland Security in 2004.

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