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Company restructuring, merging & acquisition should be done in concert with ERP system tuning up or building up. Someti

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

mes you should consider switching to cheaper and more efficient ERP solution

The MicroCap space may be viewed as a jung

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

Examples of combination products may in

le containing many hungry predators who may view you and your company as just another meal. Within six degrees of sepa

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

ration from nearly everyone in the American business community, unfortunately, you are likely to meet someone who has be

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

en victimized in a reverse merger transaction or some other transaction that was poorly structured, ill conceived and de

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

Combination pro

signed to fulfill the selfish interests of a few. Divestitures or Spin-Offs may substantially improve you cash flow:

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

• Sometimes companies can be burdened by assets or divisions that are not relevant to their current business focus.

• T

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

his can cause financial problems and can create a lack of clarity on the part of their shareholder base.

• What is the

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

solution? Maybe your company should consider getting operationally and financially back into focus by spinning out a div

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

ision or divesting itself of an asset?

• Usually you need specialist to assist in identifying a target for divesting or

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

spinning off, valuing the asset, finding a buyer and/or assisting in a public or private spin-off of the asset to your s

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

Following aspects would a

hareholders.

ERP System – structuring your business processes. It is not a secret that when you are trying to sell the

dd to the challenges in developing combination products:

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

company – first potential buyer question would be your ERP system and structuring around it.

• Do you have Accounting/

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

Inventory/Supply Chain management automation system?

• How expensive is its annual support?

• Is it general industrial

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

ERP or custom made one (risks to lose IT support)

It is common scenario when your IT budget is overburdening and you c

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

an switch to ERP system which is cheaper in software licenses cost and annual support. We saw successful scenarios:

•

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

Professional from academic institutions, pharmaceutical industries, health care indust

Switch from expensive ERP: Oracle Financials, PeopleSoft, SAP to budget ERP: Microsoft Great Plains, Navision

• Switch

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

from legacy CRM solution, such as Siebel to budget CRM: Microsoft CRM

More advanced expense reduction scenario might le

.

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

ad you to your Business Processes Outsourcing (BPO) – this is when you have your accounting and data processing done fro

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

Companies that provide selfless information through particip

m countries like India.

You can always have the option to call us: 1-866-528-0577, 1-630-961-5918, help@albaspectrum.co

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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