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Traditionally Accountants have been seen as something to be feared and a necessary evil, but things are ch

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

anging. Accountants need to look at their attitude to their clients and perhaps rethink the approach they

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

Examples of combination products may in

use. Many people feel daunted and intimidated by a visit to the Accountant and this need not be the case.

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

Adopting a new approach will ensure that Accountants keep their clients longer and are able to better un

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

erstand the needs of the individual.

Applied Accountancy is a vibrant forward looking Accountancy Practic

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

Combination pro

based in Maidstone, Kent. Owned and led by Paul Baker, a young, energetic and successful Accountant who c

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

ame from a family of Accountants. Paul has eradicated the myth that Accountants are severe and unfriendly

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 it is this approach which has led to his success. Clients of Applied Accountancy are given a personal y

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

t professional service and made to feel completely at ease when they visit the practice.

There is no stuf

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

fy atmosphere here, instead clients are treated on a one to one basis and are always guaranteed to speak d

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

rectly to Paul who will help them with whatever problem or question they may have. Paul says that "I wante

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

Following aspects would a

to get away from the image of a grey suited accountant who is unapproachable, and enjoy the fact that I c

dd to the challenges in developing combination products:

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

an build long term relationships with my clients"

Accountancy does not need to be a cold, daunting prospe

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

t and Applied Accountancy are breaking the mould in Kent and offering their clients a unique service which

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

is tailored to the individual needs of every client. Business's have enough to concern themselves with and

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

dealing with an Accountant should not be an unpleasant experience, Applied Accountancy are moving forward

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

Professional from academic institutions, pharmaceutical industries, health care indust

and taking their clients with them. Paul says "I like to get involved with our clients business and not be

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

someone who our clients see perhaps once a year, we want our clients to succeed and offer all assistance t

.

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

o them in order to reach this goal." Applied Accountancy, the future of Accounting

Accountants should be

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

Companies that provide selfless information through particip

ooking at this approach and replicating it as it can only be a good thing for both clients and Accountants

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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