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There are many firms coming up everyday due to the efforts of high and able entrepreneurs. The scenario in business is undergoing a rapid change. Various

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

companies are investing in new offices in other cities and thus diversifying or expanding their businesses. Large scale and medium scale multinational and

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

Examples of combination products may in

national level firms too are seeking expansion. There are various real estate builders lining up to offer these companies easy office spaces due to the lu

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

e of earning steady income through lease and rentals.

Risk factor
There may be certain jeopardizing factors approaching these firms. As a business m

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

n looking for expansion or diversification or a new opening, there are certain risk factors that are involved. The person making the investment may not ha

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

Combination pro

e the necessary knowledge and time to look into these risks. What can be the possible risks?

-The person needs to introspect at first, the real estate requ

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

rements and specifications for his company in the small, medium and long run. Do I actually know them?
-Do I have any idea of the base of foundation

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

specifications that I will want before as a final point before moving into the office?
-Are there any chances of any legal problems in purchasing an of

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

ice space? If yes, what can be the possible ones that have not struck me?

Usual problems

-The space that the person has bought may be too small. It me

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

ns that the proprietor made a wrong estimate of the office requirements at the start of the buy out.
-These problems of space create an unhealthy atm

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

sphere and don’t allow people to work at the level of their personal space. It may also create congestion and inefficiencies.
-The human resource dep

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

Following aspects would a

rtment may also face troubles in coordinating with the other departments. The business may thus suffer.

Tackling these problems in advance
-Profession

dd to the challenges in developing combination products:

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

l help may be needed from architects and project managers who make exact calculations and thus come up with the right size needed.
-You must analyze th

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

requirements for your firm in the coming years or on the basis of a long term, medium term and short term criteria.
-Foresight is an important need an

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

d the space available per head needs to be analyzed.
-The firm needs to look at various other perspectives such as nearness to the potential patrons,

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

the competing business houses, the suppliers and the various stakeholders of the business.
-Air condition, 24x7 electricity and water supply, broadband

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

Professional from academic institutions, pharmaceutical industries, health care indust

connection, telecom facilities, parking slots required, etc. are the various vital and prime things to be looked into, well in advance.
-Office rent,

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

maintenance charges, parking rentals, Tiffin rentals, electricity billings in the particular area and other potential unforeseen costs must be well calcul

.

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

ted.
-Approach consultants and other experienced business houses or partners and prepare a check list of the various things to be kept in mind.
-

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

Companies that provide selfless information through particip

The best option can be to outsource the responsibility to someone who is a professional in this area. A short term investment can lead to a long term gain

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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