Answers - Real Estate

When a potential owner/builder has decided to move toward the process of building a new home, I regularly see a bit of confusion where the “cart before the horse” comes into play. What I mean by that i

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 owner/builders try and concentrate on the design or plan idea before they have secured land or a lot.

I understand the excitement of the plan design process and putting on paper their ideas for thei

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

Examples of combination products may in

dream home, and let me share some insight on why it is important to have your land purchased first. Here are some considerations before sitting down with a plan designer:

1. Does the land/lot have 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.

covenants you are not aware of? What I mean by this is you should check with the previous owner, Realtor and County or City planning Department and see if there are any restrictions or covenants on wh

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

t you can actually build there.

2. What are the setbacks for the land/lot and how will that affect the size and footprint of your proposed home? A setback is designated space, pre-de

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

Combination pro

termined by the local planning Department, which is not available for your home to sit on. This is usually for right-of-ways for utilities, widening the roads, etc. So for example, if the lot you are c

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

nsidering is 50 feet wide and you have a 5 foot side yard setback, that means you have to take off 5 feet from each side leaving you 40 actual feet for the width of the home foundation. This is an issu

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

also for a City lot where you may want a side garage.

3. Are there height restrictions in the area? What is the maximum height of the roof from grade (level of the land) that you can build? May be a

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

roblem for a larger 2 story plan with a steep roof line.

4. Where are the views? Once you have the land and walk around it, you will get a pretty solid idea where you would like the kitchen, living ar

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

eas and bedrooms to face on the lot. If you have a plan already, you may find that the existing drawing does not account for the right positioning or amount of windows that would take advantage of the

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

iew.

5. Sewer and septic. If this is an acreage lot, then you need to see if the land has “perked” and what size of septic field and system you can build and how many bathrooms you would be allowed pe

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

Following aspects would a

how many bedrooms. Your Realtor and local Heath authority should be able to answer that question. A perk test is used to see how the actual soil absorbs or retains water. A failed perk test means alt

dd to the challenges in developing combination products:

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

rnative septic systems which can be very expensive. A city lot will usually have a sewer system to tie into, but check with the Realtor or local planning department.

6. Privacy. If you find a piece o

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

f property that has steady traffic on the front street, you may change your mind on where you want your master bedroom or living area to be. If you have plans already done, this may be a re-draw.

7. E

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

gineering. More and more States and Provinces are requesting engineering reviews on plans before they will issue building permits. If you find land that may be of interest to you, research the local Bu

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

lding Department and find out if structural or civil engineering is required. Better to find out now before you already have plans done that can’t be engineered for that zone.

There are many variables

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

Professional from academic institutions, pharmaceutical industries, health care indust

in the owner/builder process, especially if things are not thought out correctly or done in a specific order. I have seen too many clients spend thousands of dollars on “dream plans” only to have them

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

restrict where they can find land, are too big for the lot they found, or just don’t take advantage of the views, slope of the land, area etc. and end up either getting new plans or giving up altogethe

.

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

.

I am not saying that if you have a set of drawings done that you cannot find the perfect lot for them or that you have done something wrong. What I am suggesting, is that it would be easier and more

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

Companies that provide selfless information through particip

prudent in the early planning stages to have finding land as the priority before plans and increase your success for a great new home building experience.

© Larry J Clark AllPro Building Systems 200

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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