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Part 1 of this series described five critical components for creating a winning proposal. In some instances, these components are all a prospective client

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

needs to make a determination and award the job. Be sure to carefully review the request for proposal to determine the amount of information you need to

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

Examples of combination products may in

nclude in your proposal. Remember, each proposal is unique.

Here are five more tips to keep in mind when preparing a winning proposal.

Tip #6 – Properly Es

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

imate Job Costs

Selecting the right price for the proposed work is a delicate balancing act. Pricing the job too low could cause you to lose money on the

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

ob. Also, a bid that’s too low might be perceived by the client as unrealistic and cause you to lose the bid. Take time to properly consider the amount of

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

Combination pro

ime and materials involved in completing the tasks you have outlined and price the job accordingly.

Tip #7 – Add Meat as Necessary

Proposal requirements

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

ary greatly. If you’re putting together a proposal for a major corporation or a government job, you’ll probably need extensive documentation. Examples of a

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

dditional information that might be required include sub-contractor agreements, non-disclosure forms, contingency plans, change order procedures, risk an

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

lysis data, benchmark results and more. If the request for proposal asks for it, be sure you include it.

Tip #8 – Don’t Reveal Too Much!

When submitting yo

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

r proposed solution to the prospective client’s problem, you must not reveal too much information. You need to satisfactorily explain your approach while a

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

the same time keeping some information to yourself. Sound confusing? How about this: If you tell the client exactly how to solve the problem, the client

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

Following aspects would a

might decide to implement your solution without your assistance! You’ll lose out on the bid, not because your approach was inadequate, but because you expl

dd to the challenges in developing combination products:

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

ined it so well the client did not need an outside company to implement it.

Tip #9 – Proper Presentation

Once you’ve gathered all the important components

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

or your proposal, take time to ensure it is properly presented. Put together a Table of Contents and check that all copies of all documents are proofread

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

, smudge-free and in the correct order. Finally, insert the proposal into a suitable binder. Give the finished document a final review; it’s your last chan

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

e to correct any mistakes. Submit the proposal according to the instructions provided and make sure it is delivered before the submission deadline. If po

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

Professional from academic institutions, pharmaceutical industries, health care indust

sible, deliver the proposal in person. You never know who you’ll encounter on the receiving end!

Tip #10 – Investigate the Winning Bid

If your company is n

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

t awarded the bid, try to learn more about the company that did submit the winning proposal. Put on your investigator hat. Find out the price submitted wit

.

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

the winning bid and the approach that was proposed. Research the company itself. Use whatever you discover as a learning tool for the next time. The inf

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

Companies that provide selfless information through particip

rmation just might help your company put together the next winning proposal.

And there you have it – ten tips for submitting a winning proposal. Good Luck

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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