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Digg It - One Consultant Does Not Fit All: Hiring the Right Consultant
I constantly work with other consultants with or on behalf of my clients. Some are consultants I help my clients locate and other are consultants they have found themselves. 99% of the time, the relationships and projects have
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
a successful result, but in the remaining 1% everyone wonders what went wrong.
The business world is full of examples of consultants who end up providing less than desirable results. Sometimes, it's because the person is not r
The business world is full of examples of consultants who end up providing less than desirable results. Sometimes, it's because the person is not r
; 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
ally a consultant at all — they are in transition or just filling time between jobs. Other times, it may be the consultant is not the right fit for the organization or the project was not clearly defined.
When you hire a consu
When you hire a consu
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ltant or contractor you must have the following:
A person who is the right fit for your organization
A relationship that is set up for success at the beginning
A deal that is fair for both parties
A project t
A person who is the right fit for your organization
A relationship that is set up for success at the beginning
A deal that is fair for both parties
A project t
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
at is clearly defined
I can't tell you how much time, energy and money is wasted when these things are not in place.
An outside consultant offers many advantages to entrepreneurs and smaller businesses, such as the abili
I can't tell you how much time, energy and money is wasted when these things are not in place.
An outside consultant offers many advantages to entrepreneurs and smaller businesses, such as the abili
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
y to provide objective advice, a frame of reference and best practices from other clients, methodologies and models to gain results more quickly and permanent transfer of skills to internal resources. While external consultants
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
can be fabulous, the wrong one can create as many problems as they were hired to solve. Lack of sensitivity to the client's business and culture, threatening employees by being an "outsider" and providing "perfect" solutions t
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
at are not practical for the client's business are just a few problems I've seen.
When finding the best consultant for your needs, I suggest the following:
Referrals: Ask trusted business colleagues for names of people they h
When finding the best consultant for your needs, I suggest the following:
Referrals: Ask trusted business colleagues for names of people they h
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ave used for similar needs, and find out specifically what the results were. If they have someone that has moved their business in the right direction, they will be more than happy to give you the contact information.
Chemistr
Chemistr
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
& Rapport: Speak with and meet the prospective consultant several times before hiring. If you see the other person as a peer and a potential partner, then you are working in the right direction. If you don't respect them, or s
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
e them as merely a vendor or subordinate, please don't. You need a business partner for a particular issue.
If this person is a friend of yours, evaluate the relationship as a peer or potential partner. I cannot tell you how m
If this person is a friend of yours, evaluate the relationship as a peer or potential partner. I cannot tell you how m
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
any "friendships" have been strained due to undelivered expectations. If you evaluate the relationship as a peer or potential partner for assisting with a particular issue, things will run smoothly.
Due Diligence: Ensure that
Due Diligence: Ensure that
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
he consultant has a valid business, with business cards, website, marketing materials, letters of reference from prior clients, samples of work and proven record of delivering what you need. All consultants have different exper
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
iences but I believe real world experience is a key differentiator.
Demeanor & Tone: The consultant should look professional and act accordingly. Their language should be clear and articulate. Be aware of their tone. Do they s
Demeanor & Tone: The consultant should look professional and act accordingly. Their language should be clear and articulate. Be aware of their tone. Do they s
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
eak with you as a partner or talk down to you? I cannot tell you how many consultants I have met who forgot they were not the client. And, if you get voicemail, don't worry, it shows they are busy. The key is, do they get back
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
o you promptly?
Fees & Deal Structure: A good consultant is willing to structure the agreement in a way that works best for both of you. Consulting fees vary dramatically and work is generally done either on a project basis or
Fees & Deal Structure: A good consultant is willing to structure the agreement in a way that works best for both of you. Consulting fees vary dramatically and work is generally done either on a project basis or
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
an hourly basis. Both have advantages and disadvantages.
Proposal: The consultant should provide you with a proposal based on achieving clear business outcomes, and not a methodology. You need solutions and you need them the
Proposal: The consultant should provide you with a proposal based on achieving clear business outcomes, and not a methodology. You need solutions and you need them the
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
irst time. Every proposal should include an outline of work to be performed, milestone dates, how often you will be billed and whether payment is due immediately, Net 15 or Net 30.
And most of all: As a consultant, it's also m
And most of all: As a consultant, it's also m
.
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
y job to make sure that I am the right fit for any client's organization as well. I love working on new projects with clients but also get great satisfaction when I am able to refer a potential client to another consultant who
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
believe will provide solutions specifically tailored to their specific needs.
An outside perspective is a great asset for business owners; I hope this list helps guide you as you search for the right fit for your organization
An outside perspective is a great asset for business owners; I hope this list helps guide you as you search for the right fit for your organization
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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