Advice You - Business

Application Software Providers or ASPs, a new revolution for the business world, provide you with customized software solutions for your business processes

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

, be it accounting, human resource management, or Enterprise Resource Planning (ERP), to name a few. ASPs help you focus on core business issues by taking

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

Examples of combination products may in

are of your key system software.

ASPs combine traditional outsourcing model with Internet to deliver customized software solutions with real time services

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

ASPs are a compelling alternative to buying packaged software and implementing it in house.

Key factors: Before you decide to outsource an important soft

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

are application system of your business to an ASP, you need to consider the following:

A) Assessing your company objectives and the requirement to outsour

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

Combination pro

e business applications.
• Define your business objectives and analyze how the ASP will help you streamline business applications and to what extent.<

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

br> • Assess your current IT staff strength and their compatibility levels while working with an outside agency.
• Do a cost benefit analysis of usin

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

an ASP and whether you’re ASP helps you to concentrate and focus more on core business areas.
• Pen down the exact application requirements you want

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

o outsource, correct estimation of trouble shooting, real-time services, the scale of operations, and, most importantly, deadlines.

B) Choosing the right

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

SP specific for your business needs. • A correct estimation of your application requirements will help you choose the right ASP for your business.
•

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

ssess your ASP based on your company’s requirements and see if your ASP is an expert service provider in specific applications, which your company requires

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

Following aspects would a

.
• Check the customer profile, global support base, and financial credentials of your ASP.
• Asses the compatibility of ASP with the size and sc

dd to the challenges in developing combination products:

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

le of your business and assess whether your ASP can scale up or down according to your company’s growth.
• Be very careful about the security of your

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

ompany data and systems and go for an ASP that gives full security support for your crucial business applications.

C) Managing and working with ASPs

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

> • A clear analysis of service requirements is the first step for a smooth working with your ASP. A well-defined Service Lease Agreement (SLA) is the key

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

for both partners’ benefits.
• Spend time with your ASP in defining SLA and the scope of its work.
• Choose a specific person for defining SLA a

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd handle the working relation with ASP to this person, one point of interaction from both sides is critical and fix responsibility.
• Train your IT s

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

aff regarding the workings of your ASP and vice versa.
• Allow free flow of communication and systematic feedback mechanism to your ASP.

ASPs are

.

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

here to stay and every growing business will require their service for critical business applications. A correct assessment of what ASPs can deliver to you

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

Companies that provide selfless information through particip

organization is key to the success of your business and choosing the right partner with well-defined service requirements can help your business immensely

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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