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Top Adding - Successful Tendering - Preparation is the Key
In the article Getting Involved in the Global Development Market (available in full in
Latest News at www.globizdev.com) I commented that while tendering skills are
critical, in isolation of other key activities success is a lottery.
Preparation must
Preparation must
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
remain as a key and ongoing activity if organisations and
individuals are to expect success from their tendering involvement.
While there is no doubt that some of this preparation may require investment if site visits and the like are to occur, as the
While there is no doubt that some of this preparation may require investment if site visits and the like are to occur, as the
; 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
need to, not all preparation is costly.
So often, when working with some of the smaller organisations that seek activity in sub-components of larger projects, the tendering effort is stressful, time- challenged and often without system.
This can be m
So often, when working with some of the smaller organisations that seek activity in sub-components of larger projects, the tendering effort is stressful, time- challenged and often without system.
This can be m
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
anaged by planning in advance.
As discussed in Getting Involved in the Global Development Market, tender responses, even for sub-components, invariably require details of your team, approach and methodology, management, price and past experience. Wit
As discussed in Getting Involved in the Global Development Market, tender responses, even for sub-components, invariably require details of your team, approach and methodology, management, price and past experience. Wit
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
the
often tight timelines for the tender response, it is critical that time is spent on
ensuring the best possible solution to the project’s requirements at the best
possible price. Hence, time should be mostly devoted to new thinking, not
admini
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
strative compilation of past information.
There is no doubt that a successful track record of implementing or involvement in similar activities will be assessed and contribute to your success or failure for any tender. But this does not mean taking t
There is no doubt that a successful track record of implementing or involvement in similar activities will be assessed and contribute to your success or failure for any tender. But this does not mean taking t
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
o weeks to find and compile a list of past
experiences is time well spent – this can be done now and on an ongoing basis.
All tenders are likely to request a range of information that demonstrates your experience in past, similar activities. Informat
All tenders are likely to request a range of information that demonstrates your experience in past, similar activities. Informat
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
ion required invariably includes the
activity name, location and duration, client, project value, key personnel by name
and title, and a synopsis of the activity.
Collating this activity is obviously going to be a challenge if it requires seeking out
Collating this activity is obviously going to be a challenge if it requires seeking out
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
personnel and past team members for information, relying on memory etc. The
solution is to encourage the habit of compiling relevant information as soon as a
project or activity commences, and keeping the information current.
This can be made even e
This can be made even e
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
asier by capturing information from the beginning of a
project consistent with how a future tender might require the information
presented.
Major agencies require a Project Data Sheet (PDS, or similar name) for each project example that you are pres
Major agencies require a Project Data Sheet (PDS, or similar name) for each project example that you are pres
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
nting with your tender. This is usually one page per
example, and captures all the information required in the assessment of your
tender. I have prepared a word document that is consistent with information that
would be required by the World Bank,
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
ADB and AusAID etc, and any sub-
components within project from those agencies. This can be downloaded from the
Latest News page at http://www.globizdev.com/articles/latestnews.php (it is listed
as PDS Template.doc).
So what do I do now I have the P
So what do I do now I have the P
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
S Template?
Simply stated – start using it!
If you have a number of project examples in different formats, then consider updating the information to use this format. If you have yet to compile capability information, then this would be a useful form
Simply stated – start using it!
If you have a number of project examples in different formats, then consider updating the information to use this format. If you have yet to compile capability information, then this would be a useful form
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
at to start populating.
Importantly, as any new project or activity commences, set up a new PDS immediately and update it regularly.
Can I use each PDS just as it is for any tender I submit?
Remember that while this template is consistent with what is
Importantly, as any new project or activity commences, set up a new PDS immediately and update it regularly.
Can I use each PDS just as it is for any tender I submit?
Remember that while this template is consistent with what is
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
currently asked, it is
important to check exact tender requirements before submission to ensure
compliance.
Secondly, each tender has different considerations because each project is different, so a generic response is seldom successful. Similarly,
Secondly, each tender has different considerations because each project is different, so a generic response is seldom successful. Similarly,
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
each project you have
undertaken would have contained a range of activities, approaches etc. So, before
just adding a PDS example to a tender submission, consider what the tender’s
(project’s) focus is, and ensure your PDS examples demonstrate this
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
Occasionally a
slight re-write to place greater emphasis on a key aspect of relevance is important.
What if I do not tender for activities?
The information that the PDS template captures is useful for submissions direct to client, or as a data capt
What if I do not tender for activities?
The information that the PDS template captures is useful for submissions direct to client, or as a data capt
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ure tool for drawing information from for developing
capability documents, case-study information and the like.
Preparation is the key.
Whether preparing a tender for a complex project, or a proposal direct to a client, it is important that time is s
Preparation is the key.
Whether preparing a tender for a complex project, or a proposal direct to a client, it is important that time is s
.
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
ent coming up with the best possible approach to ensure
implementation creates the best outcomes. Taking time away from this critical
aspect of tender and proposal development to prepare Project Data Sheets is not
time well spent.
Download the PDS
Download the PDS
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
Template, a word document, in Latest News at http://
www.globizdev.com/articles/latestnews.php
http:// www.meldunn.com.au
http:// www.meldunn.com.au
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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