Advice You - Business

Registered Agent services aren't cheap. Many companies charge $100-125 per year to act as your agent

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

. So it's important for you to know 1. Do you need a Registered Agent and 2. Should you pay for one.

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

Examples of combination products may in

What is a Registered Agent

Every state requires that an LLC organized under its laws have

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

registered (or resident, in some states) agent at a physical location within the state. The purpose

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

is for the government to be able to deliver official documents to the LLC. The most likely document

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

Combination pro

are tax forms and notice of lawsuits.

Basically, the Registered Agent is the place and person with

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

in the State's physical jurisdiction on whom service of process can be done. The State wants a physi

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

cal person and place within their borders whom they can go to with taxes and lawsuits.

If you are f

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

rming an LLC in the state where your business operates, you can simply use your business office addr

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

ess. In this case, you are your own Registered Agent. This is the most common arrangement. Even if y

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

u operate your business out of your home, you can use you home address for official service.

Whe

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

Following aspects would a

n do you need to pay for a Registered Agent service?
If you don't have a physical location

dd to the challenges in developing combination products:

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

in the state where you formed your LLC, then you'll need to appoint a registered/resident agent with

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

n that state to receive official documents.

Example: You live in Missouri, but you formed yo

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

ur LLC in Nevada (there'll be another post later about why this may or may not be a good idea). Neva

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

a is going to want a registered agent that is located in Nevada to be able to serve with official pa

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

Professional from academic institutions, pharmaceutical industries, health care indust

pers--a.k.a. lawsuits and tax notices (while Nevada has no state income tax, they do have business t

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

axes, for example on gambling). If you don't have a house or office in Nevada to recieve these paper

.

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

, you'll need to hire someone who does to accept these papers on your behalf. This person is a regis

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

Companies that provide selfless information through particip

tered agent.

Many incorporation companies will, for a fee, act as your registered or resident agent

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 - Do You Need to Purchase Registered Agent Service for Your Business?

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