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1)Are you licensed? Make sure your contractor is properly licensed. In the State of Delaware, all contractors MUST be either certified by the State (if they have a statewide license), or registered with the State (if they have a countywide license). Anyone

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

can say they are licensed. Make the contractor prove it by either showing you the license or giving you a copy of it. Remember to check the expiration date, and the county if It’s a countywide license. Being licensed is the law. If a contractor cannot produce a val

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

Examples of combination products may in

d license, DON’T HIRE HIM!

If you live in a townhouse, villa, or high rise condominium building with four or more units, only a Building Contractor or General Contractor are permitted to perform remodeling work. Do not hire a Residential Contractor; he

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

would be operating outside of his license. Furthermore, hire a specialty contractor (trim, carpentry, drywall, glazing, aluminum, plumbing, electrical, mechanical, roofing, etc.) to do only the type of work the license specifies.

If you have any questio

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

s or doubts, call the Delaware Department of Business and Professional Regulation, or the New Castle County Construction Industry licensing board.

2. Do you carry general liability insurance? Make sure your contractor carries general liability ins

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

Combination pro

urance. This type of insurance protects your property in case of damage caused by the contractor and/or his employees. The insurance company will pay for the cost of replacing and/or repairing any damage that occurs.

Anyone can say they are insured. Make

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

the contractor prove it by having their insurance company FAX or mail to you a certified copy of his insurance with you named as the certificate holder.

3. Will you provide me with a written lien waiver? Your contractor should provide you with a

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

written lien waiver at the end of the job. This is a legal document, which says you the homeowner have paid the contractor in full for the services rendered and the contractor waives his right to place a mechanic’s lien on your property. If during the course of con

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

truction you receive any Notice to Owner documents from material suppliers or sub-contractors, it would be prudent to ask the contractor for a Final Release of Lien from each one prior to paying the contractor his final draw. This protects you in case the contracto

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

r doesn’t pay his material suppliers or sub¬contractors after you have paid him in full.

4. Are you a member of NARI or NAHB? NARI stands for the National Association of the Remodeling Industry and NAHB stands for the National Association of Home

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

Builders. It’s always a good idea to consider hiring a NARI or NAHB contractor. In most cases, both organizations only attract conscientious contractors interested in bettering the industry and in weeding out unprofessional contractors. In order to become a member,

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

Following aspects would a

the contractor’s background and references are thoroughly investigated.

5. Will you pull all the required building permits? Make sure your contractor pulls all required permits. This is very important. When a contractor pulls the required buildin

dd to the challenges in developing combination products:

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

g permits, you know things will be done to “code’. Also, many homeowner’s insurance policies require pulling a permit on any major remodeling to keep your home properly covered. Not all contractors will do this. Many prefer not to pull permits because of the time i

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

volved and the “hassle” with the inspectors. Some contractors may ask you to get the permits. This could be a warning sign that they are not able to pull the permit because they are unlicensed, or the work is outside of their license. A reputable contractor will pe

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

rmit every job where a permit is required.

6. Do you guarantee your work? Your contractor should guarantee his work for at least one year from date of completion.

7. Who will be In charge of the Job? Make sure the contractor o

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 foreman is on the job whenever work is being performed, - especially if sub-contractors will be used. The responsible party must be intimately familiar with every aspect of your project. If you won’t be home during the construction and must leave the house u

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

Professional from academic institutions, pharmaceutical industries, health care indust

nlocked, or leave a key with the contractor, you must feel comfortable. You can’t be worried about what is going on when you are not there.

8. Will you provide me with written references? A good contractor will be happy to provide you with refere

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

ces. You should look for a well-established contractor who can give you several client references from the last 6 months to one year. Ask for the name of the contractor’s accountant or banker. You want to ensure the contractor is financially sound and won’t be

.

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

declaring bankruptcy in the middle of your project.

9. What percentage of your business is repeat or referral business? When a significant source of a contractor’s business is derived from repeat and referral business, it usually indicates that h

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

Companies that provide selfless information through particip

s clients are pleased with the work they have received.

10. How many projects like mine have you completed in the last year? Your contractor should have experience in the type of remodeling project you want done — not just “contracting experience

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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