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Make no mistake, in the unhappy event of things going horribly wrong, it's you in the hot-seat, even if you think the accountant is to blame. So do

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

n't settle for the phonebook lottery approach. This is a VERY important decision, take your time, and do the research.

This article is a checklist

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

Examples of combination products may in

of some basic steps you can take to avoid the cowboys!

1/ Ask around! If you have friends/associates in business then ask them to recommend an acc

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

untant to you. Accountants can be invaluable if they're good and disastrous if they're bad. If you know someone who has been through a few financia

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

cycles with their accountant and still speaks well of them, that's a really good sign!

2/ In most countries, declaring you have qualifications th

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

Combination pro

t you don't is illegal. So find out what qualification your accountant has. If you're in doubt get them to confirm it in writing.

Meet your accoun

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

ant face to face in their premises. It's great if your accountant is happy to visit you at work or even at home. But when you're trying to assess t

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

eir professionalism you need to look them in the eye over a desk in their office. There are two very practical reasons for this. Firstly, you can a

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

least be fairly sure you have their real business address. Secondly seeing your accountants workplace can help give an impression of the state of

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

heir business, and their attitude to their work. If the surroundings don't look like your definition of a productive work environment, then perhaps

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

they're not, or perhaps you have different standards.

Ask your potential accountant how he/she will work, perhaps he will want to impose a set of

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

Following aspects would a

ractices upon you, perhaps this is just what you need. But on the other hand you need a system that you can understand. If he wants you to adopt a

dd to the challenges in developing combination products:

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

et of practices make sure you understand how they work.

Who will do the work? Find out if you are speaking to the person who will actually do the

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

ork on your behalf, if not, you need to speak to them.

Remember you are making the first tentative steps in what may well be a very long relations

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

ip. Think of your accountant as you would a major shareholder in your company, is this someone you'd be happy to discuss all the prickly details of

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

your finances with?

Telephone your accountant "out of the blue". He will most likely be busy, that's understandable, but did he get back to you? I

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

Professional from academic institutions, pharmaceutical industries, health care indust

's amazing how many fall at this first hurdle. If he can't be bothered to call when you're a new client imagine yourself one week from a government

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

deadline! An accountant who doesn't value your business is a liability! (excuse the pun).

This may seem a little over the top, but just remind you

.

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

self who is liable for the decisions your accountant makes! If your accountant can't communicate the decisions he makes; operate in an organised an

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

Companies that provide selfless information through particip

timely manner; and treat you with respect you shouldn't be giving him your patronage and you certainly don't want to accept liability for his work

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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As management members and business owners we detest dealing with unions in our businesses. Unfortunately, the government has allowed people to collectively bargain for compensation & wages, benefits and terms of employment. This leaves many companies at a loss for an effective labor relations strategy.

In many parts of the country, winter brings with it wet and icy conditions. This is dangerous not only for driving, but also for walking! Thousands of injuries occur from people slipping and falling because of ice and snow. Reducing injuries is possible when your employees take a little extra time and taking a few precautions to avoid slips and falls.

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