Main Subject - Business

Deciding to sell your business can be one of the biggest decisions in your life, whatever the reasons are for the sale. It is impos

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

sible not to become emotionally attached to your own business. Seeing a business grow can be a wonderful thing on the flip side dec

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

Examples of combination products may in

iding to sell the business can be gut wrenching experience.

Ideally a business owner will have prepared for the sae at least 2 yea

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

rs previously. This process is generally started by assessing the financial state of the business with a view to creating audited

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

inancial statements with future projections that show the company's revenue and potential growth.

Documentation should be put toge

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

Combination pro

ther to clearly show all transactions, this is vital information for any purchaser, it will allow the company to be easily evaluate

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

d. Information on customers should also be available; a new owner would not want to face a customer who expects to be treated in a

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

particular way, not armed with this information

All supplier and customer contracts should be examined. Terms and conditions for e

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

ch process should be available, if required. Contracts should not be coming to an end as new owner takes charge. Terminating contra

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

cts out of spite simply because you are selling the business serves no purpose at all. Remember when selling a business it is not s

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

imply about financials, it is also about keeping your reputation.

Start codifying business policies and procedures, if necessary,

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

Following aspects would a

create a handover file this file should document exactly how to best run the business including as much information as possible as

dd to the challenges in developing combination products:

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

to aid the new owner, even your thoughts on future growth and development will be useful.

You will need to review your real estate

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

leases, if your business is tied to a particular location you will need to make sure the lease is not set to expire or require ren

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

egotiation at the time you are planning to sell the company. The location of the company may discourage buyers; if so consider movi

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 a different location before you put the business on the market.

Equipment leases and material contracts will have to be chec

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

Professional from academic institutions, pharmaceutical industries, health care indust

ed so they have plenty of time to run when the business sis handed over. You will need to fully evaluate and catalogue all the comp

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

any assets.

Finally, don't forget about the employees. The loss of key employees during the sale of the business can ruin a deal.

.

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

Key employees are crucial to the new owner's success, so it's important to determine which employees are prepared to stay with the

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

Companies that provide selfless information through particip

company during and after the transition. It is important that employees don't hear about the sale of the company from a third party

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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CNBC's new show Business of Innovation is s show all business students should watch. It throws a window of clarity to business and innovation ideas that have been twisted over the years. Maria Bartiromo is very helpful with pulling out tips from the guests on the shows.

Year-end often means the annual performance review dance is about to begin. Our suggestion - don't do them at all if you're only doing once a year! Performance reviews need to be ongoing to be most effective for you and your employees.

There is one powerful strategy all event and meeting planners use to reach the level of success they really dream about. It has nothing to do with event themes or locations, or your budget. It has nothing to do with your training in the industry. What I am talking about is much more powerful, and has the potential of positioning you as #1 in your industry and to generate business you never thought possible.

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