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The small business owner or manager of a satellite or branch office of a larger company is faced with many decisions

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

when considering their office space in the Dallas – Fort Worth (DFW) Texas metro business area.

These decisions incl

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

Examples of combination products may in

de:

Where do I locate within this large geographic metroplex?
Do I locate close to my customers?
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

li>
Do I locate centrally to my employees’ homes?
Do I need easy access to the expressway system or th

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

area airports to accommodate customer visits?

The answers to these questions are complicated by the

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

Combination pro

diversity of your employee or customer locations within a 12-county region made up of Dallas, Fort Worth and 126 othe

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

municipalities including the fast growing business centers contained within Las Colinas, Irving, Grapevine, Garland,

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

Frisco, Plano, Southlake, Westlake, Coppell and Lewisville. A geographic area encompassing 9,000 square miles might

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

equire multiple office locations to adequately serve or cover your markets.

How much working capital will I have to

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

commit towards an office facility, furniture, equipment and my supporting administrative functions? How much time wi

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

l it require of my management resources to find, hire, equipment and train my required administrative functions? How

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

Following aspects would a

will I accommodate or plan for increases or decreases in my office space requirements?

This is working capital and

dd to the challenges in developing combination products:

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

anagement time which would be put to better use for prospecting for new customers or markets or to better service exi

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

sting customers.

The advantages of using an executive suite management company within the Dallas –Fort Worth busines

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

region include:

Quick, easy possession, often within a business day or two.
Short periods of com

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

mitment – as short as three or six month commitments are generally available.

Expansion possible within th

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

Professional from academic institutions, pharmaceutical industries, health care indust

building or across locations which makes incremental growth or downsizing much easier.

No capital outlay

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

beyond a security deposit is required.

In short summary, the answer for most small business owners or prof

.

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

ssionals and many branch or satellite office managers is not to lease a traditional office space, equipment it and st

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

Companies that provide selfless information through particip

aff it; but rather, to lease space from an executive suite company located within the Dallas and Fort Worth metroplex

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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