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Useful Advices - Growing Your Business and Your Bottom Line Through Minority Certification
Are you leaving money on the table? If you are a business owner who is a woman or a member of a minority and you have not become certified as a Minority or Women-Owned Business Enterprise (known as M/WBE), you may be missing out on opportunities.
Reasons to Become Certified
Why do you need certification? Well, maybe you don
Reasons to Become Certified
Why do you need certification? Well, maybe you don
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
't. Certification lets others know that your company is what you say it is-a minority and/or women-owned business. Chances are your average customer is not going to ask you for certification. Certification is required, however, when you want to do business with companies or government agencies that have supplier diversity 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
Examples of combination products may in
grams and want to ensure a level playing field for women, minority, or disabled-veteran owned businesses. While you may not have considered this as an avenue for your business, you will want to be ready to seize an opportunity, should one arise.
M/WBE Certification will also give you the ability to expose your business to pot
M/WBE Certification will also give you the ability to expose your business to pot
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ntial customers that you may not have considered nor had access to before. Many of the qualifying agencies create meet-and-greet opportunities, directories and notify you of upcoming opportunities. This alone makes the sacrifice of time and minimal fees, when going through the certification process, well worth it.
Certifica
Certifica
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ion Requirements
In order to be eligible for certification, the basic requirements are:
" The business must be at least 51 percent owned, controlled and actively managed by minority group members (Native American, Black, Hispanic, Asian- Indian, Asian-Pacific, Aleut, Eskimo, or Native Hawaiian)
" In business for at least one
In order to be eligible for certification, the basic requirements are:
" The business must be at least 51 percent owned, controlled and actively managed by minority group members (Native American, Black, Hispanic, Asian- Indian, Asian-Pacific, Aleut, Eskimo, or Native Hawaiian)
" In business for at least one
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
year
How long is my certification valid?
Recertification practices, as well as fees, vary according to the certifying agency. For example, the state of New Jersey requires recertification upon your one-year anniversary. However after that first recertification, your status is valid for five years provided you submit your su
How long is my certification valid?
Recertification practices, as well as fees, vary according to the certifying agency. For example, the state of New Jersey requires recertification upon your one-year anniversary. However after that first recertification, your status is valid for five years provided you submit your su
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
porting documentation by your anniversary date each year.
Certifying Agencies
Choosing a certifying agency should depend upon your type of business and the opportunities you want to seek. Your city and state government offices have certification processes, help and opportunities. There are a myriad of other agencies as well
Certifying Agencies
Choosing a certifying agency should depend upon your type of business and the opportunities you want to seek. Your city and state government offices have certification processes, help and opportunities. There are a myriad of other agencies as well
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
such as the NY/NJ Supplier Development Council (formerly known as the NY/NJ Purchasing Council). As per their website, "The Council strives to expand business opportunities for minority-owned suppliers by linking them with purchasers in the public and private sector. As an advocate for both its suppliers and corporate members,
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
The Council fosters relationships between corporate decision makers and targeted minority suppliers."
Are All Certifications Recognized By All Agencies And Companies Seeking M/WBEs?
With all these certifying agencies, you may want to know if all agencies and companies recognize all certifications. The short answer is not n
With all these certifying agencies, you may want to know if all agencies and companies recognize all certifications. The short answer is not n
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
cessarily. You must check with the requesting agency or company.
For example, in New York there is an agreement between the NYC Department of Small Business Services and The NY/NJ Minority Supplier Development council called the New York City Fast Track Certification
As posted on their website, "The New York & New Jersey Min
For example, in New York there is an agreement between the NYC Department of Small Business Services and The NY/NJ Minority Supplier Development council called the New York City Fast Track Certification
As posted on their website, "The New York & New Jersey Min
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
rity Supplier Development Council, Inc. ("The Council") and the New York City Department of Small Business Services (SBS) are now promoting "Fast Track certifications" that will enable Council-certified suppliers to increase their contracting opportunities in the public sector. The City and The Council signed a Memorandum of Un
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
erstanding (MOU) in an effort to increase the certification of minority-owned businesses. Under the agreement, businesses certified by The Council as a Minority-Owned Business Enterprise (MBE) will receive expedited approval of their certification applications with the City… Council-certified suppliers will have greater access
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
o contracting opportunities, better preparation to compete for City contracts, and extra navigation in the public procurement process. "
This partnership is great news for a small business looking to expand its opportunities. Many such opportunities exist, but be sure to ask the certifying agency where the certification will
This partnership is great news for a small business looking to expand its opportunities. Many such opportunities exist, but be sure to ask the certifying agency where the certification will
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
e recognized and question the companies providing opportunities what certifications will be accepted. Be sure to do this before making a commitment to become certified with any agency as many fees, if required, are not refundable.
Getting Help
The process of applying for M/WBE Certification may be daunting for some. It
Getting Help
The process of applying for M/WBE Certification may be daunting for some. It
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
may require more focus and time than you are able to spare, but don't give up. There is a tremendous amount of assistance available for you on both a free or fee basis. Each agency provides its own sources of assistance. In New York City at the official website, www.nyc.gov, you can find applications, help documents, email a
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
dresses and contact numbers for assistance. They also provide monthly training seminars where you can get help from trained certification specialists for free.
To get help and information on M/WBE certification in your locale, begin with your city and state government. Check their websites or call for help. Your local libra
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
ies will be able to assist as well. The internet is a cornucopia of information. Use any of the various search engines such as Google (www.google.com) and Yahoo (www.yahoo.com). Changing the word phrases as you search, i.e. minority certification, mbe agencies, or minority business opportunities, will pull up different resul
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
s giving you a wider array of information.
There are also tremendous local organizations that are ready and willing to give you assistance. Begin with the Small Business Administration and their local arms known as SBDCs or Small Business Development Centers, often times located within the city colleges (http://www.sba.gov/l
.
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
calresources/index.html). Your local library is a tremendous resource as well.
There are times when all you need is someone to pull you through the process. An executive, administrative or virtual (remote) assistant can work wonders in this area, from researching the qualifying agencies and fees to helping you to complete ea
There are times when all you need is someone to pull you through the process. An executive, administrative or virtual (remote) assistant can work wonders in this area, from researching the qualifying agencies and fees to helping you to complete ea
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
h step of the application. Choose someone thorough and detailed because a detained application can cost you time, money and missed opportunity.
If you are qualified for certification and you don't get this done you've left money on the table, possibly thousands of dollars or more. Can you afford not to become M/WBE Certified
If you are qualified for certification and you don't get this done you've left money on the table, possibly thousands of dollars or more. Can you afford not to become M/WBE Certified
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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