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1. Pre-approval the first thng you should do is make sure your buyer is pre-approved so you don’t waste any time with som

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

eone who can’t afford your home. Have the potential buyer get an unconditional lender pre-approval letter from a financia

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

Examples of combination products may in

l institution. This letfer says the potential buyer has been pre-approved to purchase a home for a certain value.

2. Pur

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

hase agreement give the potential buyer your purchase agreement provided in this kit. This must be completed and signed b

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

y the buyer and the buyer’s spouse, if married. Encourage the buyer to use your purchase agreement if they have their own

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

Combination pro

because your purchase agreement will be in your best interest. Make sure it is in your best interest.

3. Earnest money d

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

eposit schedule an appointment to meet with your potential buyers to review thier offer when they have completed it. Ask

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

or 24-48 hours to review the offer. Have them bring an earnest money deposit in certified check form for anywhere from 2%

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

-5% of the purchase price of your home. This money is yours if the buyers back out of the sale as specified in the purcha

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

e agreement. Make sure the amount you require will deter buyers from breaking their contract and that you will be adequat

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

ely compensated if they do. The check can be made out to you or it can be made out to the title company you have chosen t

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

Following aspects would a

o work with. If you choose to have the title company hold it for you they will hold the money in a special account until

dd to the challenges in developing combination products:

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

he deal is closed.

4. Counter offer after you have reviewed the offer, if there are terms or conditions that you don’t a

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

gree with, line it out and write your changes in. You should initial the changes with your spouse and return to the purch

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

ser. The potential buyer should initial changes they make or initial next to your changes if they agree and resign the pu

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

rchase agreement with the new date.

5. Accept the offer you accept the offer by signing the purchase agreement with your

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

Professional from academic institutions, pharmaceutical industries, health care indust

spouse.

6. Copies are to be distributed at follows:

to the buyer: one copy of signed purchase agreement, sellers disclo

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

sure statement, lead based paint disclosure.

To title company: one copy of all of the above plus the earnest money depos

.

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

t made out to title company or copy of check made out to you.

For yourself: all of the above forms and your earnest mone

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

Companies that provide selfless information through particip

y deposit check or copy of check made out to title company.

The title company will takes over from here. Congratulations

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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