Subjects - Business

There are certain things that must be considered before you hire a business planning consultant: The following are some of the most important things to consider when hiring a consultant:

You must have a contractual agreement.

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

The consulting agreement sets out the parameters of the relationship, specifies the services to be performed, and sets forth the timeframe in which the work needs to be completed. Both parties should sign the agreement.

You must c

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

Examples of combination products may in

heck the consultant’s background. The skills and abilities of consultants vary widely. You should conduct your due diligence and check references to help you determine if the consultant is right for your business.

Be sure th

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 no one in-house can do the job. Companies commonly fail to consider the various skills of their employees before hiring a consultant. Take the time to re-read the resumes of your staff before you spend more money than necess

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

ry to hire a consultant.

Be sure to check the compensation scale. Check the going rate in the industry and do some research to find out the pay range for the services you require before overpaying a consultant.

The paymen

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

Combination pro

t for expenses should be spelled out in the consulting agreement. The consultant will expect his or her expenses to be covered, and these should be discussed in advance and spelled out in the consulting agreement so they do not com

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

e as a surprise when they appear on the invoice.

Be sure the consultant is available on the time schedule you require. Make sure the consultant is available to work on your project on your schedule. If the consultant accepts y

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

ur job but cannot start for three weeks, you need to know that in advance to be certain that your deadlines will be met.

Conduct a thorough hiring interview. Take the interview process very seriously with consultants just as yo

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

u would do with prospective employees. A consultant you hire will be involved in the future of your business, and it is imperative that you conduct a comprehensive interview.

Have the consultant sign a letter of confidentiality.
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
b> Consultants are free agents, and you need to keep in mind that they may work for your competition after completing your project. Therefore, you must have a signed letter of confidentiality from the consultant to protect your trade
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ecrets and confidential information.

Clearly describe the project. Be sure that the consultant and you are not on the same page from the start to avoids misunderstandings and complications later on.

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

Following aspects would a
to your staff. Your employees start need to know who this person is and why they are asking for files or asking about certain projects. Introduce the consultant to your regular employees, especially those with whom he or she will
dd to the challenges in developing combination products:

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

The consultant must have marketing and finance skills and experience. They must understand the U.S. industrial and business climate. They must understand your company and the industry. They must know who your com
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
petitors are and how they do business. Be sure the consultant shows you the research they have done in preparing your business plan.

The consultant must do more than just write a business plan. A business plan needs to reflec
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
a carefully thought-out business strategy for growth and profitability. Your business plan consultant must work with you to develop and refine your business strategy. The consultant needs to meet with you several times to learn, think
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
through, and discuss your marketing, financial and operating strategies.

Before you hire a consultant, do your research and look at the work the consultant has done in the past. Be sure the consultant has the academic credentials an
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
d experience necessary to do a comprehensive business plan. Be sure the consultant knows how to prepare a business plan that will meet your needs, whether it is for raising capital, applying for business loans, meeting IRS requirement
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
, or supporting grant requests.

Jo Ann Joy, Esq., MBA, CEO The future of your business starts here!

You may contact Jo Ann by phone at (602) 663-7007, by fax at (602) 324-7582, by email at joannjoy@Indigo Bus
.

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
iness Solutions.net, and by mail at 2313 East Ocotillo Rd., Phoenix, AZ 85016. I have many published articles, and I will send any article to you free of charge. Most consultations are free.

For information about other important
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
legal, tax, and business topics, free copies of articles, or EBooks, please visit our website at u>www.IndigoBusinessSolutions.net. Copyright 2006. All rights reserved. Indigo Business Solutions is a registered trade name.

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

Tags

Links

Subjects - How to Hire a Business Planning Consultant

Related Articles: