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Top Articles - Competitive Advantage Through Regulatory Compliance
If you are among those managers who feel that the increasing number of regulatory compliance mandates have interrupted your
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
life, it is time that you think again. The heading of this article may seem a little out of place but if you are willing t
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
open your mind and participate in the debate than you could very well end up agreeing that regulatory compliance can creat
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
a competitive edge.
Let us clearly establish the parameters that define success or competitive advantage in the modern da
Let us clearly establish the parameters that define success or competitive advantage in the modern da
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
y business culture. The edge would mean new customers, longer customer retention cycle, better brand image, and, not to for
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
et, a step up in the credit rating ladder.
The Arguments in Favor:
What are compliance requirements? Well, they are manda
The Arguments in Favor:
What are compliance requirements? Well, they are manda
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
ory steps or guidelines laid down by the government for doing things right. The government demands that several procedures
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
be followed while accomplishing a task. These procedures in turn require better management, precision in operations, and ex
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ended internal and external control.
The end result of compliance is a better quality economical output. Add-ons, trained
The end result of compliance is a better quality economical output. Add-ons, trained
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
abor, fewer manufacturing errors, more accountability, and, of course, legality is all results of regulatory compliance.
T
T
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
e Arguments Against:
Think hard before you write regulatory complaints. For example, the initial administrative expense im
Think hard before you write regulatory complaints. For example, the initial administrative expense im
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
plied in such regulations could hurt but it nevertheless acts as a strong defense especially in fighting competition. You n
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
w know your basics and are ready to put up a fight.
Second is the time spent trying to achieve compliance. You may feel li
Second is the time spent trying to achieve compliance. You may feel li
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
e the time could have been spent on attaining higher ratings and more customers, but you may find out that you are doing ju
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
st that by following the mandates.
Just because they are imposed, it does not mean that they are valueless. Regulatory com
Just because they are imposed, it does not mean that they are valueless. Regulatory com
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 combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
liances are intended to benefit the society as a whole. A careful scrutinizing of the principles and facts save the economi
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
s a much larger pain of financial scams and misappropriations. Diligent follow-up can certainly put your name up front and
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
gather much more customer and investor confidence for you. A means of positive publicity, rather than one-sided marketing,
.
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
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
cts as much in you favor as any other intended promotional campaign could.
The requirements might at times seem complex an
The requirements might at times seem complex an
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
therefore act as an inhibiting force, but the right guidance and advice can certainly make them a booster of your business
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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