Useful Advices - Business

I have read many technical documents that are collages of past documentation. The most offensive violation of this is when the technical document is a proposal. Why? Prop

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

osals are used heavily for companies to remain in business. If the proposal looks like an agglomeration of past proposals, it could cost them the contract. I have seen pr

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

Examples of combination products may in

posals where writers even forgot to omit the last organization’s name and paragraphs had dissimilar phrases. Many businesses commit these mistakes, even Fortune 500 compa

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

ies.

There are three easy steps that can help you avoid such errors:

1. After carefully reading the proposal instructions, make sure to have a brainstorming session

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

o you can use your old proposals appropriately. One of the last companies that I worked for needed my assistance in writing the biggest proposal of their company’s hi

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

Combination pro

tory. I remember the first “brainstorming” session I had with them. Instead of focusing on the agency’s needs and the Request for Proposal (RFP) requirements, they were m

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

re focused on how they could use past proposals and technical documentation. That meant a lot of “cut and pasting”—a recipe for disaster! As I quietly took notes, I asked

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

, “The proposal said they wanted innovative ideas they had not heard before. What are you doing to address this subject?”

A pause.

I asked a few more questions, and the

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

it dawned on me. They overlooked many of the key components that the agency emphasized in the RFP.

Pretend you are an outsider (if you are unable to do this, have someo

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

e from another department assist you). Read the entire RFP, or a similar document, in detail. While you’re reading it, write down the requirements of the RFP. Then come u

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

with questions that you would want answered if you were the organization.

2. Do research on the organization. Identify past issues and criticisms on the contract the

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

Following aspects would a

need assistance with. Another company needed my assistance in writing a proposal in response to a RFP. I read the government agency’s RFP and did research on the typ

dd to the challenges in developing combination products:

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

of technology they needed built. I found reports from the Inspector General and even the General Accountability Office (GAO). When I spoke to the Proposal Manager, I ask

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

d him if he read those reports and could assist us in tailoring the proposal to fit their needs. He looked perplexed. “GAO has a report on the agency?”

Do plenty of rese

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

arch. Check newspapers, government agencies’ sites, and the organization’s site. I guarantee that many times they need assistance with this.

3. Edit at least TWICE if

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

you will be using old documentation in the proposal. After the proposal is complete, thoroughly edit the document at least twice to ensure that you do not have any pa

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

Professional from academic institutions, pharmaceutical industries, health care indust

t organizations’ names, the flow is superfluous, and you have satisfied all of the RFP’s requirements.

Many people skip on this part, yet it is probably the most importa

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

t in guaranteeing that a proposal won’t be kicked back or thrown away. If you can afford it, have someone outside the company edit the document for you. It is always bett

.

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

r to have a fresh pair of eyes edit a document to eliminate bias.

If you remember these three easy steps, you will avoid those issues when mixing past documentation into

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

Companies that provide selfless information through particip

a new proposal. You can apply these three principles to any document (i.e. design document, white paper, grant). Laziness is frowned upon—just be sneaky and use this tips

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.usefuladvices.org.ua/article/36067/usefuladvices-Proposals--Three-Easy-Steps-to-Mix-the-Old-With-the-New.html">Proposals - Three Easy Steps to Mix the Old With the New</a>

BB link (for phorums):
[url=http://www.usefuladvices.org.ua/article/36067/usefuladvices-Proposals--Three-Easy-Steps-to-Mix-the-Old-With-the-New.html]Proposals - Three Easy Steps to Mix the Old With the New[/url]

I know a lot of people thinking that working from home and owning a home based business means that they don’t have to work very hard or very much. They believe that is enough to join to programs and all will run automatically, making money even when they sleep.

Most of the management courses have strategy game playing as a subject. I am a marketer. My product price is say - x. my competitor introduces his/her product at price -y. what should I do with my price that will increase my share. Because whatever I do, my competitor will manipulate their price.

An enterprise opts for outsourced product development to manage costs, boost bottom line and save time for core activities. There are several reasons can be cited for outsourcing option. But the moot question is -When does outsourcing make sense?

Tags

Links

Useful Advices - Proposals - Three Easy Steps to Mix the Old With the New

Related Articles: