Subjects - Business

Accounting is one area which every company has to maintain but mostly not part of their core business. It is also one of the areas that keep changing every year and the company has

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

to aggressively keep up with the changes in the tax code. This includes managing your books till you finish up with paying taxes. For a company to survive in an environment where mi

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

Examples of combination products may in

takes are costly and dependent on how well they can play the accounting game correctly, they should have an outstanding accounting department. This could either be in-house or compl

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

etely outsourced to some good service providers.

Accounting is a critical component of your business and care should be taken to employ the best and the bright. These accountants s

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

ould be ahead of every tax and book keeping game. They should stay abreast with every tax code changes. More so over they should be capable of finding ways to save more for the comp

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

Combination pro

ny. But having an in-house team for this is often very costly given the price of publications to subscribe and the time it takes to go through complicated laws. The best would be to

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

outsource this task and have a limited in-house staff to oversee the operation. This is one area where a separate expert entity makes a lot more sense and you can rest assured that

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

the team is keeping up with the changes and saving you money and help you run the core business without distractions.

Here is the top 5 list of accounting areas that you should out

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

source to the experts:

1. Book Keeping: this involves maintaining your sales ledgers, purchase ledgers and cash books.

2. Payroll: This is a lot complex than you think, choosing t

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

e right software and constantly keeping up with the tax codes is by itself a very complex task. In this age the base salary is just one component, the majority is based on performan

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

e and achievements. These factors are highly volatile, and add a different equation to payroll processing. Outsource this first if you have more than 20 employees.

3. VAT: Value ad

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

Following aspects would a

ded tax is one of the very complex tax regimes which every company should seek advice with professionals. The customs and excise is a very task intensive area and having in-house ex

dd to the challenges in developing combination products:

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

erts for small companies who do a lot of imports and exports is a costly misuse of scarce resources. You should find out the folks who can keep up with the complex tax changes and w

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

ho can ensure the returns you file are accurate without any overpayments or underpayments. The overpayments are one time loss, but underpayments will come back to haunt you.

4. Fin

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

ncial Accounts: The financial accounts should be maintained and shown at very strict time limits. This is usually a race against time. If you have an in-house team, they may perform

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

this well in normal situations. But sometimes there may be some audits where the time to resolve issues will be a big pressure point and your in-house staff cannot just take it. It

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

Professional from academic institutions, pharmaceutical industries, health care indust

is better that a good service provider manages this area for you.

5. Company formation and corporation law: This is one service which is wildly popular for its outsourcing ability.

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

You can easily get the services of a good company to take care of the company formation and registration aspects. You need someone to talk to the tax authorities on your behalf. The

.

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

y should also be very well versed in the particular industry segment your company is in. This ensures the tax opportunities and relief available for your company can be fully utiliz

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

Companies that provide selfless information through particip

d and proper structure could be employed.

There are a few more that could be outsourced but these are the major areas you may want to evaluate in your next board or company meeting

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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