Useful Advices - Business

ADD Clients can be quite a challenge to deal with, especially if you’re accustomed to focused clients who can stay on topic

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

for more than ten minutes at a stretch. Visiting their place of business can be both exhausting and fruitless, as they flit

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

Examples of combination products may in

from one task to another, their minds never fully engaged on one task, their attention span barely long enough to register y

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

our presence. Speaking from vast amounts of experience with this type of client, I have found several methods that may be he

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

lpful.

1. Unless you work on-site, meet with them away from their place of business. If they’re unable to

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

Combination pro

monitor what’s going on they may still be distracted, but much less so.

2. Make them aware that your hourl

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

y rates are based upon the time they spend with you, and not the amount of work that is done. This type of client can be the

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

worst time wasters, so letting them know that your time is valuable and will be charged accordingly may garner their attent

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

ion. I learned this only after too many unplanned excursions that the ADD client wanted to go on – being an agreeable sort b

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

y nature, I went along and ended up resentful at the imposition on my time. Remind the client of this periodically because t

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

ey’re bound to forget.

3. Ask the client to put down the phone and let calls go to voicemail when you’re w

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

Following aspects would a

ith them. You can suggest that the information you need will have a will be more accurately conveyed if YOU aren’t distracte

dd to the challenges in developing combination products:

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

d by their other activities.

4. Do not get caught up in the swirl of chaos that can surround an ADD client

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

. Remind them, gently or forcefully, that your top priority is making sure their books are accurate.

5. Ex

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

plain to them very clearly what you need, then write it down so they have something to refer to. Then say it again and again

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

, as necessary. Don’t assume that because you told them once, they’ve retained the information. With so much activity going

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

Professional from academic institutions, pharmaceutical industries, health care indust

on in their heads all the time it’s more of a surprise that they remember anything at all.

6. Remain calm.

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

Remember that you are on the outside of this particular phenomenon, and that the client will greatly appreciate your calmne

.

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

ss and stability.

Paying attention to the client’s specific needs and abilities can mean the difference between a satisfied

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

Companies that provide selfless information through particip

client who is happy to pay what you’re worth and a difficult working relationship that satisfies neither you nor the client

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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Useful Advices - Bookkeeping for ADD Clients

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