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Just Other Articles - Accountant and Financial Services Selection
An accountant can be more than just a person who prepares the accounts and talks to the taxman for you.
Over time you will find that your accountant can become a valued business advisor. Remember that they are deal
Over time you will find that your accountant can become a valued business advisor. Remember that they are deal
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
ing with a spectrum of local businesses of various types.
A natural by-product of this is that they will have:
A natural by-product of this is that they will have:
- Many contacts – some probably very relevant to your own business
- Dealings with the
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ocal bank managers and a good idea of what they expect for applications such as financing in particular, the style of business plan they like to see presented to them
The respect of other local organisation
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 particularly banks and other professionals that will reflect well on your business
A lot of experience in dealing with the local tax office and regulatory bodies
Professional qualification
Professional qualification
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
I can’t stress enough that if you want to have a solid, long term, happy working relationship then you should always use a qualified accountant.
You will of course always be able to find other cheaper alternat
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ves but consider this:
- Do they have enough experience and training to carry out the regulatory and governmental obligations you have. Remember, when the Inland Revenue is handing out fines for late paymen
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
t or non-compliance, there is only one person who suffers – you
Are they up to date with the latest legislation regarding taxation and company law? You see there is one main reason why establishe
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
practices charge a higher rate and that is because they take a professional attitude to keeping their knowledge up to date. They attend regular updating seminars and courses which can be quite expensive as it is sp
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ecialised knowledge
Other offices
You should find out whether the office you are dealing with is one office as part of a larger group or just a single practice.
This is relevant if your business
Other offices
You should find out whether the office you are dealing with is one office as part of a larger group or just a single practice.
This is relevant if your business
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
is more than just a single entity such as a shop or small local business. You see as your business grows so will your need for technical assistance. There comes a point when you may outgrow a local practice and nee
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
to move on to a medium sized practice where the specialised knowledge is split amongst its senior staff.
In a larger practice there may be a partner who specialises in obtaining corporate finance, several tax speci
In a larger practice there may be a partner who specialises in obtaining corporate finance, several tax speci
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
alists in different areas and partners who specialise in investigations and due diligence work, in addition to those staff who do the day to day work of accounts preparation and tax returns.
You will usually obtain
You will usually obtain
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
more efficient service from one practice due to pooling of ideas than having several advisors from different organisations.
Your choice of practice will ultimately come down to what size your business is and what e
Your choice of practice will ultimately come down to what size your business is and what e
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
xpansion plans your foresee. There is nothing wrong with choosing a larger practice, just consider whether there is any cost implication.
Existing clients
You should consider whether the practice you are re
Existing clients
You should consider whether the practice you are re
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
iewing already have clients in the same line of business as yourself. This can be advantageous if you are in a specialised field as your accountant will already be up to speed on your particular requirements and thi
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
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
may translate into a reduced fee.
Recommendations
Naturally you should seek recommendations from as many people as you can. Particularly take note of advice given by business associates.
In addition, cons
Recommendations
Naturally you should seek recommendations from as many people as you can. Particularly take note of advice given by business associates.
In addition, cons
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ider these avenues for advice:
- Local banks and other professional advisers
- Try to seek permission to contact existing clients for references, this can be an informal way of gathering great inform
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
tion
See whether the practice publish regular articles in say local newspapers giving free advice to readers. This can give an indication as to the expertise of the practice.
Where to find
Where to find
.
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
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
your accountant
There are several places to look including:
There are several places to look including:
- Simply, walk down your local high street and call in at reception for practice brochures
- Yellow pages – usually the professional b
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
dies will advertise the names of local authorised practices
Local papers and other publications
Search online
Contact the institutes below for a list of practices in your area
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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