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Contingency plans are absolutely critical for first year business success. A contingency plan i

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

s what will help you deal with the curve balls that get thrown at you. Despite your best researc

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

Examples of combination products may in

and planning, you will encounter surprises: good and bad.

When you start your contingency pla

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

n you need to list out anything you can think of that will either positively or negatively impac

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

your business. There are a number of things that you should consider for your contingency plan

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

Combination pro

including:

Concentrating on a niche - what contingency plan can you put in place if your niche

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

ries up or turns out to be unable to support your business? Labor market issues - do you need 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

contingency plan for a lack of availability of contract workers or employees? General comfort

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

ith ASP software - if clients don't need the services you provide, are you able to branch into

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

different service markets? Strategic alliances between competitors - if there are mergers or al

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

iances in your industry have you thought of how your business can react and stay alive?

A thoro

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

Following aspects would a

ugh contingency plan address 15 - 20 reasonable possibilities that could affect your ability to

dd to the challenges in developing combination products:

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

emain profitable. These are things that are outside of your control that you must react to. You

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

r contingency plan only needs to cover a one-year time horizon but it should be revised often.

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

he Bottom Line On Contingency Plans

You don't want to be caught without a contingency plan. Th

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

ings happen - some positive, some negative. Your ability to weather the ups and downs of your bu

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

Professional from academic institutions, pharmaceutical industries, health care indust

iness will depend heavily on the thought and time you put into your contingency plan. Your abil

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

ity to deal with the unexpected is what will keep you on track for success, or derail you comple

.

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

ely.

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

Companies that provide selfless information through particip

. {Attention Publishers: Live hyperlink in author resource box required for copyright compliance

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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