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Companies listed in the NYSE had to get an internal audit department ready before 31 October making sure the new audit heads could evaluate the scope of their

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

departments work, as well as how to comply with the new Sarbanes Oxley laws. They had to hire new directors and get an audit plan ready due to the provisions m

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

Examples of combination products may in

ade in the Sarbanes Oxley law passed in 2002. The companies had to hire personnel as well as assign the new department a budget, determine how they will docume

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

nt compliances and how much work to assign the audit department. Sarbanes Oxley Act of 2002 has created a revolutionary change in the corporate governance as w

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

ell as internal control for companies listed in the NYSE. This Act was passed to check fraud and bring reliability to financial reporting.

The act made it man

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

Combination pro

datory for companies listed in NYSE to determine financial reporting risks, design ways to manage the risks, fix problems creating such risks, analyze the effe

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

ctiveness of the control measures taken, re test and re-document anew.

Sarbanes Oxley Act had a profound impact on the internal auditors, who with their exper

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

tise in business process analysis, risk management financial and operational control testing, who were suddenly in great demand and every company seemed to nee

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

d their services. Thus apart from their normal duties, the auditors found more and more of their time was taken up trying to comply with Sarbanes-Oxley provisi

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

ons. Companies that correctly and intelligently utilized the expertise of auditors have seen unprecedented success as they provide valuable guidance in several

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

aspects of running a company such as risk management, prioritizing goals, streamlining operations, device ways to cut operating costs, help the company get ma

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

Following aspects would a

ximum tax benefits etc.

Sarbanes Oxley Act caused auditors to scrutinize financial reports carefully, as the consequences of reporting them wrong were severe.

dd to the challenges in developing combination products:

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

The companies CEO and internal Audit head had to certify the accuracy of the financial statements personally.

Sarbanes Oxley and Internal Audit:

Sarbanes-Ox

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

ley act has made it mandatory for internal audit departments to

Be consulted regarding internal control of the company.
Be consulted regarding

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

enterprise risk management strategies.

Helping the company to identify, classify, and assess the risks, eliminating risks, as well as evaluating the con

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

trol methods adopted periodically.

Recommend ways to control risks.

Assisting in designing an internal control program for the company

Rec

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

Professional from academic institutions, pharmaceutical industries, health care indust

ommending and drafting procedures for internal control of a company.

Help maintain the control repository.

Are project managers to all efforts ta

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

ken to comply with section 404?

Help design control effectiveness tests and help conduct the test and evaluate the results.

The act thus crea

.

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

ted a great demand for companies to have good internal audit departments and their expert counsel. The role of auditors and internal audits in managing and gui

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

Companies that provide selfless information through particip

ding the company increased significantly due to Sarbanes-Oxley Act. There are firms that offer services as well as products to help run businesses successfully

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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