E-Folder - Business

If you have a Request for Proposal that has been issued from a potential or current client company or a government agency, then, first, you have a bid/no bid decision to make.

To make this decision you should c

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

arefully read the RFP in its entirety. If any information is unclear, usually, the RFP will give information on how to and with whom to communicate with. Guidelines are usually in place concerning people who ca

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

Examples of combination products may in

be contacted, and the methods of communications, frequently these days it is by email only and the questions and answers are sent to everyone who received the RFP.

After reading the RFP, put the information in

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

o four categories: 1.) Administrative/logistical/ contact information, 2.) Legal clauses and specifications that will govern the contract, 3.) Requirements for solution development, scope of work, technical expe

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

tise, etc., and 4.) Format guidelines. Now, make a list of all the contradictions, missing elements, inexplicable jargon, and unclear statements that you need to raise questions about at a bidder’s conference o

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

Combination pro

email to the contact person.

Once you have a thorough understanding of the RFP, you can determine the answers to the following questions:

What is the real purpose of the RFP?
What is the s

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

ope and magnitude of the requirements?

What confidence do you have that you or your organization can fulfill all the requirements?

Determining the purpose of the buyer (such as, “Are they

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

just trying to get information?”) and the strength of your competition might indicate that winning the contract would not be possible or not be in the best interest of your business. You want to focus any effort

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

as time consuming as writing a proposal only on the RFPs which present opportunities for quality contracts.

Outside the government, there is no standard for RFPs. They may be clearly understandable documents o

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

poorly written and difficult to understand in terms of the actual requirements and scope. For example, an RFP might go out for a one-hour training video. What are the real requirements you are being asked to

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

fulfill? Do they want you to just film an existing training session as it is being presented, so all you are doing is shooting the film and doing a little editing? Do they want you to work on the development of

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

Following aspects would a

the training, the scripting, filming high-quality with full crew, edit, add animations or interactive exercises, and do they want it connected to a Learning Management System?

You must make sure that you unders

dd to the challenges in developing combination products:

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

and the true scope of the requirements before you make your decision to put in the effort of writing a proposal.

Start work on a requirements checklist at this time, and continue updating through the communicat

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

ons and bidders’ meeting. For now, this checklist will give you the scope and magnitude of the project. When your proposal is complete, the checklist can be used to verify that you have covered all the requirem

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

ents and did not miss anything in calculating your costs.

Once you understand the scope and magnitude of the requirements, you may find that winning the contract might not be cost productive. Do you have the 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

pabilities (staff, resources, and finances) to fulfill the requirements, or would you need to take into account sub-contractors, new equipment, additional inventory, or even a loan for upfront expenses? Would y

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

Professional from academic institutions, pharmaceutical industries, health care indust

u need to form an alliance with a competitor or complimentary company to fulfill all the requirements.

If two or more companies or sub-contractors are involved, then the process of preparing the proposal become

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

more complex; exactly what items of fulfillment each of the companies or sub-contractors will be responsible for must be addressed.

Making a chart of your analysis can help you make your bid/no bid decision.

.

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

ook at the chart below: A “yes” should be checked in a large percentage of the boxes.

At this point, you will have determined whether or not the purpose of the RFP is valid, know the scope and magnitude of wha

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

Companies that provide selfless information through particip

you would be bidding on, and have determined whether you could fulfill the requirements. Now you only have to answer one question: Is this job worth the time and effort required to write and excellent proposal

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.e-folder.org.ua/article/16447/e-folder-Making-The-Bid-No-Bid-Decision-on-RFPs.html">Making The Bid- No Bid Decision on RFP's</a>

BB link (for phorums):
[url=http://www.e-folder.org.ua/article/16447/e-folder-Making-The-Bid-No-Bid-Decision-on-RFPs.html]Making The Bid- No Bid Decision on RFP's[/url]

Running a home business has always interested people especially mothers and the home bound. However starting the business is not a game. It does not involve simply setting up your computer and beginning. People are often deterred from venturing further, when they become aware of some of the complexities included with regards to taxation, insurance and others.

UPS or United Parcel Service has been around for a long time now. UPS shipping has been considered an expert in the industry and has made a name for itself with its efficiency and customer service.

Licensed Practical Nurse (LPN) Careers Licensed Practical Nurses provide the most amount of direct patient care within the nursing category of healthcare. If you’re interested in a healthcare career...

Tags

Links

E-Folder - Making The Bid- No Bid Decision on RFP's

Related Articles: