Main Subject - Business

Companies and businesses that either lack time, expertise, or both, often outsource human resource tasks to an

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

outside company. In the past, small businesses did not have the opportunity to outsource functions such as HR,

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

Examples of combination products may in

s the market was lacking in options to do so. However, a comprehensive range of HR services are available these

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

days to cater to companies of all sizes, including those with up to 75 employees. Human resources management is

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

one of the most widely outsourced businesses in the market.

Until recently, companies used to outsource only p

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

Combination pro

yroll and benefits administration to other companies. However, it is a relatively new phenomenon to outsource p

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

ractically all HR activities like business processes and employee management. HR business process outsourcing h

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

s grown immensely over the years. Recruitment outsourcing can perform all the recruitment functions like the as

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

essment of departmental needs and placement of employees in appropriate departments.

Human resource outsourcin

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

has become increasingly popular, especially for employee data organization and payroll calculation. However, m

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

ny organizations prefer to handle recruitments and termination of employees locally. An external organization h

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

Following aspects would a

andling it may not understand the internal requirements of the company.

Outsourcing saves a lot of money as ma

dd to the challenges in developing combination products:

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

y service providers are able and willing to perform the tasks at low costs. Outsourcing enables companies to co

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

centrate on their focal functional areas. However, the main disadvantage with outsourcing human resource functi

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

ns is that there is no personal contact between the employees and the human resource department. This means tha

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

the personnel problems of employees cannot be easily addressed or communicated. Occasionally, outsourcing may

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

Professional from academic institutions, pharmaceutical industries, health care indust

also pose a security threat in terms of breach of sensitive employee information.

Cost is the deciding factor

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

hile selecting an outsourcing service provider for most companies. On the other hand, some companies place more

.

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

importance on the compatibility of work ethics. It is advisable to hire outsourcing service providers that have

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

Companies that provide selfless information through particip

adequate experience in human resource functions and the necessary infrastructure and staff to carry out the job

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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