Advice Pool - Business

If your company is -- in the make-buy-outsource decision -- taking the step to “Buy” it will face a lot of challenges.

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

This doesn’t mean that a decision to Make would leave you with less uncertainties. If you do opt for addressing your res

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

Examples of combination products may in

ources in making your own systems you will face the same level of challenges, but these ones will stay within your compa

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

ny. You do not have a benchmark, because you have chosen to build a proprietary solution that is specific only for your

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

situation. There is no way to check whether you did a good job.

In this sense, the step to Buy is a new one. You have c

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

Combination pro

hosen to go for a more best-practice approach and in the area of Enterprise Resource Planning; there are many vendors 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 provide packages.

Such a package should not only serve your company but many others too. There are various ways of 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

andling such a ERP selection process. In this article I’ll focus only on the in-sourcing question. This is a question ab

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

out architecture.

The Supplier of the ERP Package – the architect – has constructed the package according to specific p

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

rinciples. This is visible in the style of the solution. Also, the design of the functionality (of the package) is focus

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

ed according to the demands of a target group. This would result in a scope that addresses the ERP package. Thus, the pa

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

Following aspects would a

ckage is the result of architecture; ideas that a made concrete in the solution to solve a need in a specific area (scop

dd to the challenges in developing combination products:

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

e). In this particular case: an ERP problem.

The problem behind ERP is how to optimize your internal process. This is n

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

ot a simple equation, but rather a complex question of “aligning” or “integrating” the various activities in an optimal

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

way. This is most of all an informational problem.

The solution found by each specific ERP supplier will differ accordi

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

ng to their architectural approach. It is this approach that you should match with your own.

So the question of selecti

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng an ERP package is about selecting an approach that would best fit your own organizational style and character. In oth

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

er words, it should match your business profile.

This can be done by assessing the architecture behind the ERP solution

.

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

and compare this with your business profile. This comparison (Quick-scan) is something that you could plan at the level

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

Companies that provide selfless information through particip

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.advicepool.org.ua/article/23372/advicepool-Insourcing-an-ERP-Supplier--A-Quick-Match-of-Profiles.html">In-sourcing an ERP Supplier - A Quick Match of Profiles</a>

BB link (for phorums):
[url=http://www.advicepool.org.ua/article/23372/advicepool-Insourcing-an-ERP-Supplier--A-Quick-Match-of-Profiles.html]In-sourcing an ERP Supplier - A Quick Match of Profiles[/url]

Customer Service at new and used auto dealerships is a must to increase repeat business and referrals. In post customer purchases those dealerships, which constantly rated higher in satisfaction, had the biggest growth rates and indeed always out sold the other dealerships which did not. In fact even metro car dealerships were beaten out by rural dealerships often enough and the ones that did always rated higher in customer Service.

You've got a great idea, you are pretty sure that what you have will sell, you've even got some cash together. What else do you need?

One of the universal laws of success is that financial success follows hard work done with honesty. Help enough people get what they want and you will get what you want too. The internet would be a much better place if we all watched out for each other and provided good value for all of our customers ensuring that no one was scammed by unethical businesses.

Tags

Links

Advice Pool - In-sourcing an ERP Supplier - A Quick Match of Profiles

Related Articles: