Advice You - Business

The Florida Department of State, Division of Corporation is the division of the Departm

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

ent of State to contact for questions about incorporating in Florida.

The Florida Depa

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

Examples of combination products may in

tment for Incorporating provides an online public access network and telephone answerin

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

system. Through their online network, the Department for Incorporating allows for ele

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

tronic certification and electronic filing services. This streamlined approach helps b

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

Combination pro

siness owners more efficiently incorporate in Florida.

The Florida Department for Inco

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

porating has many responsibilities. In addition to providing certifying, and providing

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

forms for, incorporation, the Department ensures that corporate names, fictitious names

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

trademarks, and service marks are not duplicated. They also cross-reference informati

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

n with the Florida Department of Revenue on a regular basis to identify foreign entitie

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

doing business in Florida that are not registered with the Division of Corporation.

T

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

Following aspects would a

e Department provides business owners with the opportunity to electronically research b

dd to the challenges in developing combination products:

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

siness entities. Using the Department's database-driven computer program ("SunBiz"), b

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

siness owners can access all of the fictitious name filings dating back to January, 199

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

, as well as all corporation annual reports since January, 1996, and all corporation fi

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

ings since November, 1997.

These digital records help alert entrepreneurs to previousl

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

Professional from academic institutions, pharmaceutical industries, health care indust

registered corporation names, in order to prevent duplication of business names, as we

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

l as potential trademark and service mark infringements. In addition, the digitized pr

.

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

cess of incorporating a business in Florida allows business owners to more efficiently

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

Companies that provide selfless information through particip

ncorporate, so tbat they can get on with the important work of running their businesses

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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Advice You - The Florida Department of Incorporating: Digitization Drives Efficiency

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