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In United States we have different states with different minimum wage laws depending on the cost of

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

living in that region. US laws shelter employees in a way that allows every US citizen to earn 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

ir living. Since an employee has a lot of benefits included in employment contract, the company do

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

expect the best out of them.

The first step to it is employee time tracking. In the workin

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

g hours every employee is allowed to take breaks for lunch, tea etc and its always time bound. Also

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

Combination pro

it is very important to understand that your working hours start at 0900 hrs and you be there by th

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

at time. Since we all know that when the working hours complete at say 1700 hrs, we don't like to s

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

tay a minute beyond that. Now its the job for the administrator, human resource department to see t

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

o it that an employee gives the paid working hours in full.

This is where proper time trac

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

king of the working hours for every employee plays a very important role. Again here, it has to be

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

utomated that helps in no manipulations. A step further to it is when the same thing is done on a c

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

Following aspects would a

omputer and the whole setup is outsourced to a payroll managing company, the headache and biasness

dd to the challenges in developing combination products:

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

is released. An employee comes into the office, punches into the system the in time, that goes into

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

the third party data server. While taking breaks, they again punch in the break time and reason, s

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

ame when returning and when they go back from work. The whole process is automated and payrolls are

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

programmed considering the wage packages. So when a payroll manager extracts the data at the end of

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

Professional from academic institutions, pharmaceutical industries, health care indust

the month, all they need to do is make payments according to the already done calculations by the

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

automated system.

Right from doing your processing manually, using computer softwares to a

.

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

utomated system, its all about technology.

With the developing technologies we see not onl

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

Companies that provide selfless information through particip

y the impact on organizations however its also moving vertically inside as well...

Paul

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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