Advice You - Business

Outsourcing is the strategic use of outside resources to perform activities traditionally handled by internal staff and resources. Small business owners can outsource non-core functions to specializ

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

ed and efficient service providers. It is required of businesses to hire special contractors for particular types of work or to meet the demands put forth by sudden spurts in the workload. Recently,

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

Examples of combination products may in

the trend of partnering with firms whose capabilities complement their own giving them an access to resources that were beyond their individual reach has come up. The difference between simply subc

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

ontracting and outsourcing is that outsourcing involves the wholesale restructuring of the corporation around core competencies and outside relationships.

As a consequence, has emerged a new class

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

of skilled entrepreneurs – the Virtual Assistants.

What is a Virtual Assistant?

A Virtual Assistant (VA) is an independent entrepreneur providing administrative, creative and/or technical services

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

Combination pro

. Utilizing advanced technological modes of communication and data delivery, a professional VA assists clients in his/her area of expertise from his/her own office. A VA completes your projects usin

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

g his or her own equipment, and carries out the work through email, fax, telephone and postal service. Therefore, the location of your VA is not important. This gives you a liberty to look for profe

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

sionals best suited to your needs located anywhere on the globe. Since they're paid only for time-on-task, businesses can hire several VAs in dispersed locations and have 24-hour support -- paying f

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

ar less than an employee or temporary would cost for such comprehensive assistance.

The services offered by each VA differ according to his/her skills. The list of services includes general adminis

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

tration services, database and website development, graphic design, internet research, sales support, presentation preparation, telephone answering, bill payments, travel arrangements, bookkeeping,

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

desktop publishing, computer training, medical/legal transcription… the list is endless! Not all VAs offer all of these services. However, by being part of VA Networks, your VA can guarantee client

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

Following aspects would a

satisfaction by a qualified VA. If your VA cannot complete your task, he/she will find another VA who can.

Why to outsource the work to a VA?

The primary benefit of outsourcing is econom

dd to the challenges in developing combination products:

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

izing since the VA can do it cheaper. VAs only charge for actual time worked.

By outsourcing to a VA rather than hiring an in-office assistant, you will never need to pay employment insurance,

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

vacation pay, sick pay, or contribute to retirement plans and worker’s compensation.

A VA has his/her own hardware, software, training, etc. thereby reducing your capital investment. So there i

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

no wear and tear on your office equipment or a need for special equipment.

Engaging a VA gives you time allowing you to do what you do best. You can focus on delivering the higher value and se

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

rvice to your customers.

As skilled VAs are chosen to perform particular tasks, they can do it better as they do it all the time. It is their business.

Like you, VAs are entrepreneurs and

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

Professional from academic institutions, pharmaceutical industries, health care indust

understand the needs of businesses today, ensuring the success of their clients. VAs value each and every client; it is because of these clients that VAs can ensure the success of their own business

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

es.

The resources of the VA can give your business access to technical advances you would not normally have access to.

With modern day communication, projects can be accomplished withou

.

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

t ever having to meet the client face to face. With the growing ease of the Internet, finding a VA almost anywhere in the world is quite simple to accomplish. More so in the developed nations like

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

Companies that provide selfless information through particip

USA, Canada, Australia, UK and many other European countries the VA industry is highly organized. The potential of developing countries like India can too be exploited to provide skilled VA services

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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