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Individual Voluntary Arrangement, IVA is an alternative to bankruptcy - which could pr

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

ovide you with a real solution to your debt problems.

An Individual Voluntary Arrange

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

Examples of combination products may in

ent (IVA) is an alternative to bankruptcy. If you have a substantial amount of unsecur

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

d debt an IVA could be your best solution.

IVAs are controlled by government legislat

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

on and can only be set up by licensed Insolvency Practitioners. An IVA acts as a legal

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

Combination pro

y binding agreement between you and your creditors, freezing interest charges on your

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

debt and setting an affordable monthly payment amount over an agreed fixed period (usu

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

lly 5 years).

It is important to remember that you should only consider an IVA if you

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

have sufficient money available to contribute towards repaying your debts each month o

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

additional assets which could be taken into consideration.

Disadvantages of Bankrupt

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

y

Notices placed in the press
Potential loss of assets such as your home, busin

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

Following aspects would a

ess and car
Long term effect on your ability to apply for a credit or a mortgage

dd to the challenges in developing combination products:

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

Restriction to work within certain professions or hold a position of office

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

Your utility suppliers – gas, electricity etc – informed
Your bank and building

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

society accounts closed

IVA could help you with:

The unpaid balance of your debts is

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

written off – as much as 75%
One affordable monthly payment, usually for five ye

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

Professional from academic institutions, pharmaceutical industries, health care indust

ars
Protects you from further action by your creditors
Your creditors are

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

egally bound by the terms of the agreement
No uncertainty: you know how much you

.

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

have to pay
Alternative to bankruptcy
No public notices: an IVA is between

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

Companies that provide selfless information through particip

you and your creditors

Bankruptcy is not only option when getting out of serious debt

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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