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Main Subject - Why and How to Work with a Consultant
A good consultant provides specialist abilities and experience, innovative ideas, second opinions (reality checks), unbiased appraisals, and new approaches.
A good consultant will leave you with tools, plans, and materials, and will transfer knowledge and resources to help you use them.
Avoid making mistakes and wasting time and resou
A good consultant will leave you with tools, plans, and materials, and will transfer knowledge and resources to help you use them.
Avoid making mistakes and wasting time and resou
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
rces. A small investment and timely, professional advice can mean savings and increased revenues in the future.
Adding the services of a consultant can make a difference when time or human resource constraints would otherwise mean a lost revenue, market, promotion, or funding opportunity.
Know your limitations and expect a consultant
Adding the services of a consultant can make a difference when time or human resource constraints would otherwise mean a lost revenue, market, promotion, or funding opportunity.
Know your limitations and expect a consultant
; 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
to know theirs. You may have someone on staff who will volunteer to create advertisements, a website, or a marketing plan--but if they aren't truly qualified, you could be paying later to undo damage or make up for missed opportunities. A good consultant will also refer you to other specialists or obtain the services of subcontractor
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
s when they need to complement their own expertise.
You are uniquely qualified to handle many aspects of your own business. Hiring a specialist, when necessary, can free you to do what you do best and make the most of your resources.
HOW TO WORK WITH A CONSULTANT
Find a specialist with experience in your industry!
Get to know the c
You are uniquely qualified to handle many aspects of your own business. Hiring a specialist, when necessary, can free you to do what you do best and make the most of your resources.
HOW TO WORK WITH A CONSULTANT
Find a specialist with experience in your industry!
Get to know the c
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nsultant(s) and work together informally to help them prepare a proposal that addresses your objectives. You can often get some good, free assistance in clarifying these objectives.
Don't waste the consultant's time if you aren't serious about evaluating their proposal, and don't seek so many proposals that none of the consultants who
Don't waste the consultant's time if you aren't serious about evaluating their proposal, and don't seek so many proposals that none of the consultants who
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
respond have a good chance to be hired (You should generally keep the number of applicants in the running to four or fewer). Do expect the consultants to ask good questions and learn about your business.
Avoid consultants who say they have immediate solutions or feel ready to talk about details, design, technology, or implementation
Avoid consultants who say they have immediate solutions or feel ready to talk about details, design, technology, or implementation
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
before they have begun to understand your business and objectives°™look for a careful approach!
Clarify your specific goals and larger objectives, and state these in writing to the consultant when you request their proposal. Remain flexible about these goals, since you are paying for the advice of the consultant about these matters--p
Clarify your specific goals and larger objectives, and state these in writing to the consultant when you request their proposal. Remain flexible about these goals, since you are paying for the advice of the consultant about these matters--p
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
erhaps some of your goals could be refined or modified!
Prepare a rough budget range for the consultant. A good consultant will not simply bid the maximum amount, but should give you a few price options depending on the scope of their services. They will tell you if the budget is truly unrealistic and can help you re-evaluate your ob
Prepare a rough budget range for the consultant. A good consultant will not simply bid the maximum amount, but should give you a few price options depending on the scope of their services. They will tell you if the budget is truly unrealistic and can help you re-evaluate your ob
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ectives or propose dividing the project over multiple phases. Maintaining an open dialogue about budgets and prices is preferable to developing an adversarial relationship during the bidding phase, which can lead to misunderstandings, wasted resources, and poor outcomes for the project.
Remember to include your own monetary and human
Remember to include your own monetary and human
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
resource costs in your internal budget estimate. Also allow for any costs associated with materials, transportation, or other expenses that a consultant may need to pass on to you. Clarify how expenses will be handled.
Clarify the timeline for the project. Remain flexible about the deadline, if possible, and realize that a fast-appr
Clarify the timeline for the project. Remain flexible about the deadline, if possible, and realize that a fast-appr
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
oaching deadline may impact the price quoted by the consultant. Expect the consultant to prepare a project outline that meets this timeline. Realize that it is not uncommon for a project with an unrealistically short deadline to end up being finished long after the same project would have been if you had allowed an extra few days or w
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
eeks from the start.
Sign a written contract with the consultant. This can often be as simple as signatures on the proposal submitted by the consultant, if all important matters were covered in that document.
Establish a project manager or producer to be the main contact for the consultant and to be responsible for all major decision
Sign a written contract with the consultant. This can often be as simple as signatures on the proposal submitted by the consultant, if all important matters were covered in that document.
Establish a project manager or producer to be the main contact for the consultant and to be responsible for all major decision
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
. Make sure this person has the knowledge and authority to make decisions and allocate necessary resources. The consultant should also assign one person from their staff who will have final responsibility for decisions and will handle most communication with you.
Maintain regular communication during the project, between project mana
Maintain regular communication during the project, between project mana
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
gers/producers on your staff and the consultant's. Expect to be shown incremental progress and to be asked to give your approval at major project milestones. Make sure you formalize these important decisions in writing--these milestones and approval areas should usually be agreed upon at the beginning of work. Do, however, trust your
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
consultant and avoid micro-managing every detail and piece of work.
Before the project begins, agree upon cost and deadline implications of any change requests made by you, or changes to the scope of work, should these be necessary. Change requests and "scope creep" are common causes for disagreement and strained relations between cli
Before the project begins, agree upon cost and deadline implications of any change requests made by you, or changes to the scope of work, should these be necessary. Change requests and "scope creep" are common causes for disagreement and strained relations between cli
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
ents and customers--recognize that "minor changes" add up quickly and can sometimes make the project financially untenable for the consultant.
Conversely, if both parties have communicated well, and been realistic in their objectives, you will often find that a good consultant will make an extra effort on something, just to make sure
Conversely, if both parties have communicated well, and been realistic in their objectives, you will often find that a good consultant will make an extra effort on something, just to make sure
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
ou are happy with their services.
If something does go wrong with the project and relations begin to be strained, agree to take a break from the work for a couple of days or more. It will often be far easier, afterward, for both parties to understand the other party's point of view, to reach compromise, to correct a misunderstanding i
If something does go wrong with the project and relations begin to be strained, agree to take a break from the work for a couple of days or more. It will often be far easier, afterward, for both parties to understand the other party's point of view, to reach compromise, to correct a misunderstanding i
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
n a way that is satisfactory to all, and to get back to work.
Finally, make sure you will know how to use (and update, where relevant) new materials, documents, and plans created by the contractor. Include resources for training in the budget.
IN CONCLUSION
By following these guidelines, you should be well on your way to good result
Finally, make sure you will know how to use (and update, where relevant) new materials, documents, and plans created by the contractor. Include resources for training in the budget.
IN CONCLUSION
By following these guidelines, you should be well on your way to good result
.
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
s on your next project! While these may at first seem like a lot of unnecessary rules, or barriers to a speedy completion of your project, they will actually prepare for smooth and timely completion. It is much better to be clear about things from the start than to have to repeat work later; or worse, have a major disagreement which w
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
ill strain relations and prove beneficial to neither party.
There are many good consultants available who can bring specialist expertise and good management skills to your projects. A little extra help and relevant information might be a great investment in your future success. Best of luck with your work!
(Seattle, USA; August 2004
There are many good consultants available who can bring specialist expertise and good management skills to your projects. A little extra help and relevant information might be a great investment in your future success. Best of luck with your work!
(Seattle, USA; August 2004
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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