Advice You - Business

Before reaching the negotiation stage of selling any business a lot of hard work should have been carried out on both

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

sides. The vendor must ensure his company is totally ready for the sale and any potential purchaser should have carr

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

Examples of combination products may in

ied out due diligence.

Negotiations can be complex and time-consuming, and more often than not break down, sometimes

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

at a very late stage; this can be very stressful for both parties. Saying all this if the right approach is taken b

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

y both parties from the outset there is a better chance of a deal being struck that both parties are happy with.

The

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

Combination pro

vendor and any potential purchaser should set their own goals from the very start so both are fully aware what they

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

want to get out of the negotiation process. Having a clear plan for both sides should prevent either side from taking

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

the lead during the negotiation process. Both parties should keep to their objectives: a good negotiator will always

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

win the more important issues and let the other party to win the minor ones.

Prior research and due diligence is al

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

ways invaluable during any negotiation process. It will show the vendor that you have a true picture of their company

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

; this can be used to strengthen your bargaining position. A good purchaser will attempt to discover any weaknesses i

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

Following aspects would a

n a company so this can be exploited; on the other side a good vendor will attempt to highlight the company’s strengt

dd to the challenges in developing combination products:

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

hs.

The use of basic psychology in the negotiation process is often used: a common tactic is for the purchaser to tr

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

y and understand the aspirations of the vendor. Most people become emotionally attached to their business and could h

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

ave personal friends within the staff. Understanding this is a very important tool for a successful negotiator. A goo

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

d tactic used by the vendor would be to highlight how well his particular sector is growing year and year and how wel

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

Professional from academic institutions, pharmaceutical industries, health care indust

l the economy is doing and how well the purchaser will fair in the future.

I will finish by saying negotiation is a

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

natural process in business; both sides should be fully prepared and if possible enjoy the process. Through good nego

.

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

tiation it is possible for both sides to come out of the deal happy.

If you would like any more information on this

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

Companies that provide selfless information through particip

subject then please visit our website at www.bizseller4u.com.

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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