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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

own to analyzing a few key factors.

The higher each of these factors rate with y

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

Examples of combination products may in

u, plus the combination of them all, the better your potential for return.

Indus

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

try - Is the business's industry expanding or contracting?

Trends - Will you be

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

head or behind the trends?

Timing - Are you early or late in the product & indus

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

Combination pro

ry life cycle?

Products - Do they provide value for money to the end user?

Uniq

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

ueness - Does the company have any exclusivity, patents, etc?

Demand - How big i

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

the market for the products & services?

Longevity - How long could the products

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

last in the market?

Future - Are there more products "in the pipeline"?

Compet

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

tion - Who else are you marketing against?

Profitability - Are there good profit

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

margins?

Compensation - How much can you earn?

ROI - How soon can you return yo

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

Following aspects would a

ur initial investment?

Leverage - Do YOU have to do all the work or can you earn

dd to the challenges in developing combination products:

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

overrides?

Company - How long have they been in business?

Management - Who's ru

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

nning the company?

Legality - Does the company trade legally in all aspects?

Pu

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

lic or Private - Is the company listed on the Stock Market?

Marketing - How, wha

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

, why, when, where?

Global or Local - Does the company market worldwide or only

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

Professional from academic institutions, pharmaceutical industries, health care indust

local?

Internet - Are they "On the Net" and E-Commerce enabled?

Tools - Are you

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

supplied with business tools to make your life easier?

Training - Will you be tr

.

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

ained?

Commitment - how much time and/or money is required from you?

Lifestyle

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

Companies that provide selfless information through particip

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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With climate change becoming more real and obvious, the realisation of the need to 'go green' is now becoming far more mainstream. Green issues are therefore, possibly unsurprisingly, also having an impact on the freight forwarding industry

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