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If you hate bookkeeping, you are not on your own. For most small business owners 'bookkeeping' is a major pain; a real chore. If you have to choose between selling your products and s

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

ervices or keeping your books in order - the books lose every time?

But it would be good to :

know your cash position

and know the bank balance before 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

statement arrives

Have reports and guidance on your profitability?

You want to be able to explain where your figures come from to the tax man i

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

he should ask. Would you play football, cricket or golf and not bother to keep the score? Of course not, we all want to be in control of our businesses, but for the small

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

business owner this has never been easy.

Give serious thought to 'outsourcing' your bookkeeping to an expert, either an online bookkeeping service or a traditional bookkeeper.

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

Combination pro

ng>Isn't it best if my spouse does the bookkeeping?

In many small businesses the owners spouse will keep the books. Of course, they want to help each other, and to keep cost

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

to a minimum. However, this can sometimes be a bad move.

If they are competent and enjoy doing it - then good. But remember your business is your livelihood, it is important that th

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

e books are written up on a timely and accurate basis.

If the job is done by someone competent

A Accounting costs should be minimised, good books = an easier job

B You should be pr

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

ovided with useful information throughout the year. Such as:

The balance on your current account, taking into account cheques you have written which the bank don't yet know about.

Y

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

ur profit for the month, compared to the same month last year.

or Profit for the year to date, compared to the same period last year.

An aged debtors list.

The cost of paying someo

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

ne competent to provide this information, perhaps just a few hours each month, can be a very rewarding investment.

Will buying Sage or Quickbooks or similar solve my bookkeep

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

Following aspects would a

ing problems?

Firstly, these and the other similar packages are marvelous tools for small business owners. However the purchase of the tool does not implement the system. If

dd to the challenges in developing combination products:

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

you are going to use the system 'in house' make sure you set off on the right track. Get someone experienced to help set up the 'chart of accounts' and the opening balances. Make sure

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

you are confident on making entries and reconciling the bank account.

Be aware of the saying "rubbish in, rubbish out", bad books means more work at the year end. At the extreme, yo

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

ur accountant may have to cast the books aside, and re-write the whole years figures - expensive.

We don't really need to reconcile the bank?

"Reconciling the bank"

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

just means making sure that the books are in agreement with the bank statements. The bank rarely make mistakes, so it usually means making sure you haven't missed anything in the book

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

Professional from academic institutions, pharmaceutical industries, health care indust

keeping.

And YES it absolutely has to be done. If you don't do it, your figures won't be reliable, and your accountant will have to do it, and he/she will charge for it.

Wha

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

t 'accounts' do we need in our 'chart of accounts'?

The software normally sets up the essential balance sheet accounts, such as a bank current account, a VAT account and deb

.

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

ors and creditors. Often it is necessary to add a bank savings or second account. Also a cash account might need to be set up. If it isn't clear how to do this, just set up a new bank

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

Companies that provide selfless information through particip

account, and call it 'cash'.

The profit and loss accounts can be tailored to your business. Don't have too many accounts, 20 to 30 is usually enough, 50 or more is probably too many

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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