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REGULATORIUM.COM

Regulatorium

Welcome to the Regulatorium. We are your one stop regulatory information and intelligence site to create and build tools for your regulatory armamentarium and strategy. As well, we offer a variety of regulatory services to the pharmaceutical and medical device industry for all phases of clinical investigations, marketing applications and post marketing support with a focus on regulatory intelligence, including:. Regulatory submissions and maintenance. CTD compliant formatting and paper publishing.

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Welcome to the Regulatorium. We are your one stop regulatory information and intelligence site to create and build tools for your regulatory armamentarium and strategy. As well, we offer a variety of regulatory services to the pharmaceutical and medical device industry for all phases of clinical investigations, marketing applications and post marketing support with a focus on regulatory intelligence, including:. Regulatory submissions and maintenance. CTD compliant formatting and paper publishing.
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Regulatorium | regulatorium.com Reviews

https://regulatorium.com

Welcome to the Regulatorium. We are your one stop regulatory information and intelligence site to create and build tools for your regulatory armamentarium and strategy. As well, we offer a variety of regulatory services to the pharmaceutical and medical device industry for all phases of clinical investigations, marketing applications and post marketing support with a focus on regulatory intelligence, including:. Regulatory submissions and maintenance. CTD compliant formatting and paper publishing.

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1

Regulatorium ~ Strategy

http://www.regulatorium.com/strategy.html

Give us a product and we can help craft a strategy for the US only or on a global basis. Strategic services include:. Construct global regulatory strategy including:. Research appropriate end-points that are acceptable for different countries. Research past precedence for development of regulatory strategy. Conduct Gap Analysis for NDA approvability or IND acceptability. Create Regulatory Development Plans. Create Draft Package Insert or Target Product Profiles. To request our services, please fill out a.

2

Regulatorium ~ Submissions

http://www.regulatorium.com/submissions.html

At any stage of drug, biologic or medical device development we can provide the following regulatory affairs services. Create the request for meeting letter. Create the meeting minutes. Compile all needed documents. Publish it for submission to the Agency. End of Phase I Meeting. Write and file any updates to the IND. End of Phase II/Pre-Phase III. New Drug Application/Biologics Licensing Application. All work will be provided in a Common Technical Document (CTD) format. Administrative section (Module 1).

3

Regulatorium ~ About Us

http://www.regulatorium.com/About.html

The Regulatorium is run by Meredith Brown-Tuttle, assisted by a variety of talented regulatory professionals. Almost 20 years experience in biotech incorporating all aspects of drug, device and biologics development. Her experiences include clinical research, data management, medical writing, and regulatory affairs. She has held senior regulatory positions at several San Francisco Bay Area biotech companies. She is chair of the RAPS Publications Task Force, frequent contributor to.

4

Regulatorium

http://www.regulatorium.com/index.html

Welcome to the Regulatorium. We are your one stop regulatory information and intelligence site to create and build tools for your regulatory armamentarium and strategy. As well, we offer a variety of regulatory services to the pharmaceutical and medical device industry for all phases of clinical investigations, marketing applications and post marketing support with a focus on regulatory intelligence, including:. Regulatory submissions and maintenance. CTD compliant formatting and paper publishing.

5

Regulatorium ~ What We Do

http://www.regulatorium.com/do.html

We are your one stop regulatory information and intelligence site to create and build tools for your regulatory armamentarium and strategy. As well, we offer a variety of regulatory services to the pharmaceutical and medical device industry for all phases of clinical investigations, marketing applications and post marketing support with a focus on regulatory intelligence, including:. Regulatory submissions and maintenance. CTD compliant formatting and paper publishing. Or by telephone at (510) 331-4492.

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Welcome to the Regulatorium. We are your one stop regulatory information and intelligence site to create and build tools for your regulatory armamentarium and strategy. As well, we offer a variety of regulatory services to the pharmaceutical and medical device industry for all phases of clinical investigations, marketing applications and post marketing support with a focus on regulatory intelligence, including:. Regulatory submissions and maintenance. CTD compliant formatting and paper publishing.

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