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Many small to medium business rely heavily on IT systems to successfully run their business.

If you find yourself spending more and

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

more time managing your network and computers but you don’t need a full time IT person on staff then perhaps now is the time you sh

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

Examples of combination products may in

ould consider hiring an IT consultant.

When you start looking for an IT consultant you should consider the following:

Experience.

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

It goes without saying that you need to hire a consultant who has experience in the IT industry.

You should ask the consultant the

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

following questions:

1. Has the IT consultant got experience supporting the same type of business as yours?

2. Do they have any te

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

Combination pro

chnicians on staff that holds valuable industry certifications, such as Microsoft Certified Systems Engineer (MCSE) etc? In order to

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

become certified by Microsoft, a Certified Microsoft Partner must prove their expertise in Microsoft technology and in specific bus

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

ness areas, such as financial management and supply chain management.

3. If you operate Windows Small Business Server onsite does t

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

he consulting company have a member of staff who is a Microsoft Small Business Specialist?

References. Ask the following questions

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

to the consulting companies other clients:

1. How well does the company work for them?

2. Ask whether work is done on time and on

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

budget?

3. Also ask whether the consultant responds quickly to problems.

Services. You need to ask the consulting company the fol

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

Following aspects would a

lowing questions:

1. What services does the consulting company provide? If they don’t supply a particular service will they be abl

dd to the challenges in developing combination products:

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

e to recommend a professional organization that can?

2. What levels of support do they offer?

3. Do they offer offsite support sol

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

utions or do they perform all work onsite?

4. Do they offer preventative maintenance plans?

5. What does the preventative maintena

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

ce plans involve?

6. How many hours per month are included in the preventative plans?

Schedules and fees. Find out the answers to

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

the following questions:

1. What is their response time?

2. Are you charged a call out fee?

3. Is their a minimum invoice amount?

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

Professional from academic institutions, pharmaceutical industries, health care indust

4. Do they assure a No Fix No Fee policy?

5. What are their business hours?

6. What happens if you call out of hours?

Personali

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

ty. It is important that a consultant be a technology expert, but it is also important that they be able to work with and talk to pe

.

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

ople who are not technology experts.

Final Words. Interview a number of potential consultants. Look for the information listed abov

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

Companies that provide selfless information through particip

e. This is not a time to just go with the lowest bid: you want the best for the job. After all, isn't that why you hire a consultant

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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