Advice You - Business

Let us pretend you are a forensic accountant with a large High Street accounting firm. You have been working in a large office with sea views, you

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

had a car park, your own personal assistant and four junior accountants working in your team. You always were incredibly good at what you do and

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

Examples of combination products may in

your clients know it. No one can get to the nitty-gritty of a fraudulent case quite like you do. But you hated the time wasting meetings and the o

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

fice politics and now you have quit and are working from your home office, answering the phone yourself.

You are still the hot shot you always we

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

re but will your clients still see it that way? Now you are working from home should your charge out rate still be $800 an hour as it once was or

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

Combination pro

as something changed?

You may think that nothing has changed in terms of the quality of advice you dispense and the service you provide but in re

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

ality, other subtle things have changed.

For instance, you are now out of the loop in terms of corporate knowledge, to keep up to date you may fi

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

nd you need to attend more conferences and network more.

Now you are at home your client is no longer buying the intellectual property of the cor

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

orate brand they once were. What price do you think they may have put on that? They are also no longer buying the surety of the brand -- the fact

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

that in the past people like you may have come and gone yet the company has performed regardless. Will they have the certainty they are used to in

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

terms of commitment to providing a back up if you are unavailable -- and what price do you think they may place on that?

Your client may have lik

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

Following aspects would a

ed the prestige and convenience of the High Street location and may have been willing to pay for that, and now he knows your business does not car

dd to the challenges in developing combination products:

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

ry the same overheads how much less does he expect to pay? If you are going to do all the administration jobs yourself then you may need to decrea

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

e your hourly rate as you are now diluting your $800 an hour thinking with $20 an hour secretarial services.

To keep up with your workload you ma

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

y decide to employ a secretary and two book-keepers (yours are more efficient because you don't waste their time in unnecessary meetings). You may

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

need to allow yourself an annual training and networking budget. You may also have to subscribe to professional organizations and journal subscrip

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

Professional from academic institutions, pharmaceutical industries, health care indust

tions that when charged as an expense works out more costly than when you were in the corporate world because now you are the only person using th

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

ese resources.

To decide whether you think you are still worth $800 an hour you need to build a case in your defense so you can give an explanati

.

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

n to your client. Perhaps you will decide to lower your rates because your overheads are lower or maybe you will charge more because now you are g

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

Companies that provide selfless information through particip

oing to get better qualified, specialize even further and take on fewer clients so you will become even more exclusive and valuable in what you do

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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One of the fastest ways to grow your cleaning business is to get referrals from your current customers. There may be times when a customer will pass your company's name along without any prompting from you. However, to really get your clients to work for you, it's important to encourage referrals.

You get what you pay for does not just apply to shopping. You are paying a price, whether you know it or not, at work and you are getting exactly what you pay for.

If you are a loan officer or mortgage broker on the market for a good quality internet mortgage lead, keep in mind that cherry picking your leads may be the best way to go.

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