Advice You - Business

When you draw up business plans, apart from forecasting bottom lines and sources of investment, you also need to work on contingency plans fo

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

r your business. All businesses go through a rough patch occasionally, so it is best to be prepared for any contingency. This way, you will n

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

Examples of combination products may in

ot be taken unawares by any unforeseen event. This article gives tips on how to make the best contingency plans and to be ready for all event

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

s.

Contingency Plans: Simple Practices Can Prevent Accidents.

Here are some things to keep in mind when drawing up contingency plans.

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

) Have a system to ensure that daily inspections are carried out after work hours to check that AC and lights have been switched off, no elec

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

Combination pro

trical appliances are left running, and doors and windows are shut.
2) Have a list of people or firms you can call up in case of an emer

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

gency.
3) Have a good data backup system so that you can retrieve all data you might lose due to some emergency.
4) Have a good id

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

ea of the location of the mains switches and valves for electricity water and gas. Ensure that your employees also know their location.

Cont

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

ngency Plans: A Checklist;

Here are some things to consider when drawing up contingency plans.

1) Ask your attorney to make a will that

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

provides for the future of your business in case of any unfortunate event. Otherwise, the business may get into the wrong hands owing to int

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

estacy laws.
2) Have a central information base where you have details of ABN numbers, tax numbers, and contact addresses of business p

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

Following aspects would a

artners, directors, shareholders and suppliers. Also, maintain a directory of investments, business plans, insurance details etc.
3) Le

dd to the challenges in developing combination products:

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

ve instructions to people related to your business so they can find relevant information related to your business in case of a contingency.

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

r> 4) Involve outside experts to help you draw up your business contingency plans. Take the advice of financial experts, legal advisors etc.

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

to provide for every possible event.
5) Plan for loss of market; what sector you want to invest in case your market stops existing.

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

> 6) Prepare for threats from competitors, and have a plan of action ready in case your competitors form alliances against your company.

A

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

Professional from academic institutions, pharmaceutical industries, health care indust

contingency plan helps you tide over difficulties in your business. It helps you prepare for loss prevention. A contingency plan helps your b

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

usiness recover from crime, fraud, theft, accidents, death of the owner, and other difficulties.

Therefore, if you have not drawn up a conti

.

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

ngency plan for your business yet, it is not too late yet. Invest a little time and resources in drawing up a sound contingency plan, so you

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

Companies that provide selfless information through particip

do not have any regrets tomorrow. You can hire a small business advisor to help you draw up a contingency plan that suits your business needs

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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