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Main Subject - Your Advisory Staff
I've learned important lessons over my 15 year career as a cleaning and restoration business owner and one of the more important lessons is that trying to learn every little detail about every business function will DRIVE YOU CRAZY! Having said that it's still important to understand key concepts of your business and options, but tryi
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
ng to learn all the details of taxes, the legal system, business structure, etc. will most likely stunt your business growth or add many unnecessary years to becoming extremely successful.
Your Advisory Staff
As stated above, there are functions in your business that you need to fully understand; but you can't possibly or eve
Your Advisory Staff
As stated above, there are functions in your business that you need to fully understand; but you can't possibly or eve
; 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
n need to understand every little detail. That's what an Advisory Staff is for. Let's look at some of the Advisors and how they can help every business owner, not just bigger companies.
Financial Advisor
This person knows everything about finances and how they affect your business. A well-established bookkeeper or accountant
Financial Advisor
This person knows everything about finances and how they affect your business. A well-established bookkeeper or accountant
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
makes an excellent Financial Advisor. This should be a person who is well familiar with you and your business and someone you can call on for good financial advice. Be sure this person is qualified! Uncle Louis may have run a successful machine shop, but the financial differences between a machine shop and a cleaning and restoration f
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
irm are many. Your Financial Advisor must help you with things such as structuring payroll, tax strategies, budgeting, and money management.
Banking Advisor
The allocation and disbursement of your assets - especially equipment and money - are functions familiar to a good Banking Advisor. Your Banking Advisor should work well
Banking Advisor
The allocation and disbursement of your assets - especially equipment and money - are functions familiar to a good Banking Advisor. Your Banking Advisor should work well
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
with your Financial Advisor to give you the best advice about investing in and using your assets wisely. My Banking Advisor is my bank manager. I confer with him about my asset needs and together with my Financial Advisor (my accountant) we develop strategies to help my business grow.
Legal Advisor
Your Legal Advisor helps yo
Legal Advisor
Your Legal Advisor helps yo
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
u understand and plan your business from a legal standpoint. He confers with your Financial Advisor and you to help develop succession plans and asset allocation in the event that the unthinkable happens to you. Your Legal Advisor is also instrumental in helping you map out legal strategies and advice as you grow; such as employee iss
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
es, real estate contracts, contracts with your customers (esp commercial and restoration), potential liabilities, collection efforts, and many other functions of your business. My Legal Advisor is my business lawyer whom I've known and done business with for years. He's restructured notes, helped build a succession plan, helped with p
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ower of attorney plans, made changes to forms and contracts, and pretty much keeps me out of trouble!
Business Advisors
Business Advisors are those with business knowledge and experience familiar to your situation. One of my Business Advisors is my Mentor, CJ, who taught me more in just a few sessions than I learned in five y
Business Advisors
Business Advisors are those with business knowledge and experience familiar to your situation. One of my Business Advisors is my Mentor, CJ, who taught me more in just a few sessions than I learned in five y
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
ears prior. Two more of my Business Advisors are my partners at BRC Systems Solutions - Dan Burk and Keith Collins. Yet two more of my Business Advisors are my parents, whom I bought the cleaning/restoration business from. Also on my Advisory Staff is my webmaster and marketing experts I've sought advice from over the years.
Other so
Other so
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
urces of Business Advisors can include: executives at your local Small Business Development Center, your local SBA and SCORE officers, Key personnel at your local Chamber of Commerce, successful friends and family members, Specialists who have already been where you want to be, etc. I'll bet if you sat down for a few minutes you could
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
write out a short list of potential Business Advisors that can help you grow.
Assembling Your Advisory Staff
First, make a list of the 4 types of Advisors I noted above: Financial, Banking, Legal, and Business. Think of people you know or have heard of from a trusted source that could fill these roles. One word of caution -
Assembling Your Advisory Staff
First, make a list of the 4 types of Advisors I noted above: Financial, Banking, Legal, and Business. Think of people you know or have heard of from a trusted source that could fill these roles. One word of caution -
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
pick your Advisors VERY carefully! Try to pick those who are not only on the same page as you, but are well familiar with your situation, your business, where you're at, and where you want to go.
Next, create an "Advisory Portfolio". Get a binder and Title/Divide the binder into the four Advisory sections. Notes with each of your Adv
Next, create an "Advisory Portfolio". Get a binder and Title/Divide the binder into the four Advisory sections. Notes with each of your Adv
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
isors will go in the appropriate sections. You will use this for reference about things you've discussed and planned.
Third, meet with your potential Advisors and let them know what you're trying to accomplish. Tell them that you would like them to be on your Advisory Staff. You'll both know very quickly if the potential Advisor is r
Third, meet with your potential Advisors and let them know what you're trying to accomplish. Tell them that you would like them to be on your Advisory Staff. You'll both know very quickly if the potential Advisor is r
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
ght for you. I can't stress this enough - it's your life, business, and future. If you don't think a prospective Advisor is going to work out to your benefit, don't feel bad about saying "sorry" and keep looking. Professionals understand that they can't be all things to all people.
Fourth - after you've created your Advisory Staff, c
Fourth - after you've created your Advisory Staff, 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
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
hoose the frequency of your meetings and follow through. Consider getting a couple of them together if and when their functions overlap, such as your Financial and Legal Advisors. Meetings where all of you are together are much more productive than trying to talk with each individually.
Lastly, use your notes as benchmarks for your g
Lastly, use your notes as benchmarks for your g
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
oals. For instance if you set up a budget with your Financial Advisor, check your progress at planned intervals, such as monthly at the start and at least quarterly after it starts humming along. Be sure to review your portfolio of Advisors at least once a year and see if there are any holes that need to be filled. If you're having tr
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ouble marketing, for example, consider Business Advisors who are great marketers.
Cost
There will be costs involved, especially with professionals. They have to be compensated for their time, effort, and expertise, of course. With a little bit of homework you can decide if the expertise you're looking for is worth the added e
Cost
There will be costs involved, especially with professionals. They have to be compensated for their time, effort, and expertise, of course. With a little bit of homework you can decide if the expertise you're looking for is worth the added e
.
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
xpense in a given category. When you pick the right advisors, though, you should end up saving tens of thousands of dollars and countless hours of stress. One of the smarter things I did early on in my career as a business owner was I surrounded myself with successful people in key areas I needed help with, especially Finances, Legal,
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
and Business Advisors like CJ and Dan and Keith at BRC Systems Solutions. Through their help and expertise, my business made hundreds of thousands of more stress-free dollars and faster than it would have if I tried to do it all by myself.
Create and implement your Advisory Staff and you'll be well on your way to Wild Success!
Scot
Create and implement your Advisory Staff and you'll be well on your way to Wild Success!
Scot
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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