Advice You - Business

When you have multiple pieces that are all on the same paper and same ink colors you can so

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

metimes gang or put multiple pieces up on the same press sheet. This saves on makeready, se

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

Examples of combination products may in

ups, plates and washups and can save $$$ if you are comfortable with some of the limitation

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

that you might have.

As an example let's say we are printing 8-8.5x11 brochures printed p

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

ocess on both sides. Our quantity that we want of each brochure is 5000. If a printer has a

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

Combination pro

40"(full size) press he can put all 8 of these brochures up on the same run. There is some

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

otential real savings in doing this but there are some drawbacks. First of all, if you have

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

all the brochures up on the same sheet and they are different families of colors let's say

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

a blue color, a green color, a purple color, a red color and a yellow and orange color. Bec

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

use these brochures are being printed in CMYK process screen mix you probably will have som

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

compromise on matching any one of those colors of brochures on press.

If you have critica

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

Following aspects would a

colors that you need to match too ganging pieces is not a very good idea. A printer should

dd to the challenges in developing combination products:

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

ask you if ganging is OK and tell you before he does it. Let's say that the blue and the pu

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

ple brochure are next too each other or stacked. Blue and purple in CMYK are predominantly

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

made of cyan and magenta in different screen %. If you want to make the blue brochure bluer

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

you are going to either take out magenta or add cyan. This will also affect your purple bro

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

Professional from academic institutions, pharmaceutical industries, health care indust

hure color as well.

If you don't have a product or corporate color or varying shades of sk

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

n tones that you must match ganging will save you money. The other drawback would be if you

.

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

want to reprint just part of the brochures. You need to be prepared for possibly paying mor

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

Companies that provide selfless information through particip

if you only print one or two of them. It is a good option but it does have its limitations

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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Date stamp equipment is now considered to be part and parcel of most organizations and companies. The date stamp equipment provides vital information to the organization on when any document or paper was received by the company or processed and forwarded by the company.

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Advice You - Ganging Print Runs

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