Advice Pool - Computers and Technology

Helping your business survive in the event of an unforeseen disaster: Most business failures are not from

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

bad business but from bad business practices.

Most companies that fail are the ones that have not planned

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

Examples of combination products may in

how their business will continue to function in the event of a disaster.

We put in the conventional safegu

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

ards such as alarming the premises, locking up vital areas and information, putting in fire prevention syst

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

ems.

But what thought is given to make sure that the vital data that is needed for a business to continue

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

Combination pro

is in a safe place- can be accessed and is current information.

Sales/purchases ledgers.

Do you know what

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

the company is owed?

Can you prove to your insurers what is owed and what your replacement costs are?

Bu

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

siness processes.

Where are your procedures manuals, technical drawings, and patents?

Insurances.

Where

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

are your policies kept?

Back up tapes- they are off site but what do we load them on to.

How often do we

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

back up our information? Where is it kept? On site-in your briefcase? How do we restore it.

Cheque books

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

paying in books-writing paper-invoice paper. Have they gone up in smoke?

There are a few safeguards that

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

Following aspects would a

we can put in place so that the business can continue to function in the event of a disaster. These proces

dd to the challenges in developing combination products:

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

ses do not have to be expensive or costly.

They require common sense, a little professional help and a pla

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

ce that is risk free where you can store the information vital for your survival.

We spend millions each

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

year with insurance companies, insuring for the eventuality of the business having a disaster- surely 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

e small amount of time cost & effort in making sure that you have the wherewithal to continue trading as

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

Professional from academic institutions, pharmaceutical industries, health care indust

soon as possible is the prime objective.

"BattleBoxes™” containing essential items for business continu

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

ation can be created for your company with a minimum of effort and will give you the peace of mind, so th

.

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

at you can continue the business in the event of a disaster.

Oh! And by the way ask your insurers for a

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

Companies that provide selfless information through particip

reduction in your premiums. Lowering the risk limits their exposure- why should they reap all the rewards

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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