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Answers - Private Electronic Plansroom - High-Tech Bidding
Some Construction Associations have taken the next step in the electronic bidding process. Dubbed the “Priv
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
ate Electronic Plansroom”, this is an extension on the success their existing electronic plansroom.
Existin
Existin
; 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
plansrooms permit all subscribed members to view plans and specifications on-line to assess each project be
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
fore requesting electronic or hard copy plans or driving to the association building in London.
This new ex
This new ex
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ension of service creates a private viewing room for invited contractors and subtrades only. As a designer
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
r developer, you can decide who you would like to bid your work and add them to your bidders list. As a gen
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
eral contractor, you can protect design bid quotes by allowing only trusted, preferred subtrades to know tha
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
this project is out for bid.
As a member of the electronic plan room, you have access to this service at n
As a member of the electronic plan room, you have access to this service at n
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
o extra charge. Now that’s value added.
To use this service, you would send a set of drawings and specific
To use this service, you would send a set of drawings and specific
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
tions along with a bidders list to the administrator of the Private Electronic Plansroom. The administrator
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
does the rest – including tracking all traffic and providing a CD of activity after closing.
If bidders hav
If bidders hav
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
e viewed the project and would like drawings printed, the association looks after the printing – for a small
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
fee – and will even arrange to courier the drawings to the trade. Documents are viewed in .pdf format and c
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
an be self-printed.
No software is required by the users, other than an internet connection. All software
No software is required by the users, other than an internet connection. All software
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
s web-based java script.
Trades who are not members of the electronic plansroom can access the information
Trades who are not members of the electronic plansroom can access the information
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
n a fee per project basis as well. The administrator even trains all users as required. And very little tr
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
aining is required The system is set up to be as user friendly as possible.
Projects can be updated and i
Projects can be updated and i
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
formation can be added as the project progresses – which is ideal for design-build projects. Change notific
.
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
ations are even e-mailed as required by the plansroom administrator.
This type of service frees-up designer
This type of service frees-up designer
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
, developers and general contractors to do more important tasks than chasing bidders to price their projects
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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