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There are establishments that undertake both printing as well as scanning. Scanning means professionally processing the pictu

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

res you have included in your layout for printing. Scanning for professional printing is done at high resolutions of 1500 dpi

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

Examples of combination products may in

or more. This ensures that the pictures are printed life-like and of high quality.

Before you even approach a printing or s

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

anning service you need to know clearly what are known as the specifications of your job. These include: how many black and w

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

hite images, how many color images, if color, what level of quality, the size of pictures, bleeds, registration, and so on.

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

Combination pro

f you provide all the required information along with printing specifications, the printing and scanning service will be able

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

to give you an estimate. This will be the basic cost of the project; the final bill will be based on actual costs incurred.

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

Scanning is charged on a per cm basis, and rescanning or too many corrections are always billed.

There are many kinds of sca

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

ners in use: slide scanners which scan transparencies, flatbed scanners which scan anything but have resolutions of 300-400 d

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

pi, drum scanners which are professional scanning devices and do high end scans of 1500 dpi, and more.

Scanning has now beco

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

e hi-tech and progressed beyond being a pre-press process. Many printing and scan services undertake digitizing of archival d

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

Following aspects would a

ocuments. Magazines, books, photographs, architectural plans, ledgers, invoices, legal documents, as antique prints and histo

dd to the challenges in developing combination products:

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

rical documents can be preserved for posterity by scanning. There are three viable options: bi-tonal, used for printed books

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

ith line engravings and black and white illustrations; grayscale for hand-written documents, lithographs, and photographs; an

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

d color scanning for documents, books, and photographs in four colors. These can then be stored for posterity as microfilm, c

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

mputer disks, or digital prints.

Once you have identified at least three printing and scanning services, visit each outfit a

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd met the personnel, ask to be shown around their premises, find out what kind of processes they use, see proofs of jobs und

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

ertaken by them, and ask for referrals. Be sure to find out how dependable each one is, and whether their rates are competiti

.

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

e.

To get the best service you will need to establish a friendly working relationship with the printing and scanning service

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

Companies that provide selfless information through particip

and be professional on all counts—ensure all instructions are clear and all submissions are made according to specifications

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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