Answers - Real Estate

The first thing you’ll want to do is select the contractors you want to bid on the property, and give them your Contractor Guidelines. You should be doing this even before you’ve actuall

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

y purchased the property, primarily because the bidding process could take a few weeks and there’s no reason to waste any time. It’s also a good way to make sure you can rehab the proper

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

Examples of combination products may in

y and make a profit on it when you sell it. Just keep in mind that legally, the Realtor is suppose to escort the contractors to the properties.

Once the bids are in you may find a great

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

deal of difference in the bid amounts from contractor to contractor. You can get 10 bids on the same job and they may vary by as much as several thousand. Most importantly though is tha

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

you check their itemized bid sheets to see that they are doing all the work that is to be done for that property, and that in the bid a warranty on their work is included. If they’ve fo

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

Combination pro

lowed the guidelines, then everything should be in order. Just make sure that this is so, so that you really are comparing apples to apples when discussing bids with your contractors. Ev

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

erything may be laid out quite clearly in the contractor guidelines, but you should still be verbally specific when you meet with the contractors. It is essential to meet with the contra

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

tors to discuss specifics for the property (the number of bathrooms, what has to be replaced and what can be refinished, changes in floor plan, etc.).

You also need to be aware of when

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

contractors under-bid on a project. An under-bid is when they turn in a bid that is obviously too low for what it is going to take to finish the project as desired. When this happens, it

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

s usually a good indicator that the contractor is inexperienced. You could take advantage of this situation and let the contractor learn a lesson the hard way or you could ask them to re

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

valuate their bid. Through experience you’ll learn to recognize a situation like this fairly easily.

A good rule of thumb t

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

Following aspects would a

hat I use is to multiply the expected material expenses by two. The figure produced by this equation should give the contractor enough room for costs of labor and still turn a profit. In

dd to the challenges in developing combination products:

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

some occasions (such as when a 3000 square foot property will completely need repainting), it may be necessary for the contractor to figure in a greater labor cost.

When requesting a bi

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

d from a contractor, the bid should always be in writing. Discuss with the contractor when they will have the bid submitted to you and how you will receive it: email, fax, or in person.

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

hroughout the bid process, refer back to the contractor guidelines as much as possible to enforce how serious you are about having these guidelines followed.

In my opinion it is absolut

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

ly worth your time and money to obtain all your bids prior to your purchase of the property. There will be cases when you might have a quick closing on a really hot deal and just won’t h

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

Professional from academic institutions, pharmaceutical industries, health care indust

ave the time to complete this, but that should be the exception and not the rule. On other occasions you may not be able to get access to the property before closing, for some reason or

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

nother. In those situations, just play it as smart as you can.

When initiating the bid process, be sure that you are actually getting a bid from someone that is capable and has the know

.

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

-how to complete the project. I have had plumbers give me bids on projects for roofing and siding properties. I have had electricians give me estimates on putting walls up. Don’t waste y

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

Companies that provide selfless information through particip

ur time with pointless bids from shady handymen. You should have already checked their references and work prior to asking for the bid, thereby side-stepping this whole type of situation

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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Answers - Getting Contractor Bids for Rehabbing Projects

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