Answers - Real Estate

Your goal in real estate investing should be to make the most profit in the least amount of time using as little of your money as possi

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

ble. Buying fixer-uppers and renovating them for re-sale is an excellent way to increase your profits. But how do you avoid becoming a

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

Examples of combination products may in

enovator and losing sight of your investment goals?

You must focus on becoming a project manager. Project management puts you in the p

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

sition of making sure the renovation gets done instead of doing it yourself. Project management for fixer-uppers will include finding s

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

bcontractors, getting quotes and scheduling the work.

Know What You're Getting Into

Your agreement with the seller should incl

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

Combination pro

de access to the property so you can complete inspections and uncover any hidden problems. It's best if your agreement allows you to re

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

negotiate the price or even nix the deal if major problems are discovered.

Be Flexible

When starting any fixer-upper renovatio

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

n project, realize that the process may not go as smoothly as you expect. There will always be unplanned delays and unanticipated obsta

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

les. Keep your schedule flexible, allow for some extra time, but work to minimize any delays that do occur.

Let the Professionals W

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

rk

It may seem like doing the work yourself will save money. This may be true if you're working on your own home. But when you are

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

renovating a fixer-upper for re-sale, everything you do must pass inspection and conform to local building codes. Are you sure enough a

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

Following aspects would a

out your skills to meet these requirements? You're usually better off to start with a professional subcontractor rather than trying it

dd to the challenges in developing combination products:

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

ourself and then paying to have it done over.

Hire Qualified Contractors

When hiring the pros to do your renovation work, ask

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

or references and check them out. Ask yourself if you can develop a good working relationship with the contractor. Don't rely on a hand

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

shake for your business agreement. Draw up a document that spells out what's expected from both parties.

Create a Work Schedule

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

To renovate your fixer-upper most efficiently, you'll need to put together a work schedule for the sub-contractors. Keep in mind that

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

Professional from academic institutions, pharmaceutical industries, health care indust

ome jobs need to be done before others. Remember, subcontractors don't always show up at the time or date you've scheduled. Make sure y

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

u allow for this so that one late worker doesn't wreck the entire project.

Don't enter into a renovation project without a budget and

.

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

set of priorities. Hire qualified subcontractors and let them do their job. Make sure the work proceeds according to schedule, but exp

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

Companies that provide selfless information through particip

ct the unexpected. Efficient project management of your fixer-upper renovation will pay off in extra profits when you get ready to sell

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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