Useful Advices - Business

Although still a relatively new and emerging technology, companies are quickly realizing the many benefits of using el

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

ectronic recording when it comes to storing important business documents. Believe it or not, there are still people s

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

Examples of combination products may in

ightly weary (or perhaps simply not aware) of the advantages of electronic recording. Using this process will allow 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.

ou and your company to save on the two things businesses want to economize the most: time and money.

In today’s busin

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

ss world, time literally is money. Thus, saving time directly translates into saving money and everyone likes to save

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

Combination pro

money, especially companies seeking to turn a higher profit. The time spent handling a paper document during a singl

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

transaction may not seem miniscule, but the total time spent filing, retrieving, and collating documents suddenly bec

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

omes very expensive when that time is converted into billable employee hours.

Using electronic records also saves mon

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

y by eliminating office space. Storing paper records can take up quite a bit of room; transferring to electronic docu

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

ments would eliminate all that unnecessary (and often times expensive) space.

There are a number of other, less obvio

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

s, benefits of switching from paper to electronic. First, the documents are more readily available and accessible. T

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

Following aspects would a

his is especially advantageous for companies with satellite offices and multiple locations, where the documents can be

dd to the challenges in developing combination products:

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

saved on the internet or a shared server. The documents are always ready to be viewed, duplicated, or sent online. Se

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

cond, it is more secure than using paper; electronic documents can be encrypted with multiple levels of security, all

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

assword protected. Last but not least, transferring to electronic records is a form of backup for your important docu

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

ments, should you decide to keep the paper records as well. In the case any paper documents were destroyed or lost, t

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

Professional from academic institutions, pharmaceutical industries, health care indust

e electronic copy would be available as a backup.

Electronic Recor

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

ding seems to be the most practical and economical way for businesses to store documents; it’s effortless, secure,

.

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

and reasonably priced. However, the process is not just for corporate businesses but practical to use for anyone. El

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

Companies that provide selfless information through particip

ectronic recording can be used for property records, deed filings, or any other personal document of private residents

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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