PhACT is an independent, Swiss-based consultancy specialized in European drug regulatory affairs and eCTD publishing. PhACT supports all pre- and post-approval registration projects within the European Union and/or Switzerland and supports eCTD submission projects worldwide.
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Phact GmbH
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Phact GmbH
Barbara Jentges
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Dug●●●gen , 4202
CH
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PhACT GmbH – Regulatory Affairs Consulting - Home | jentges.com Reviews
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PhACT is an independent, Swiss-based consultancy specialized in European drug regulatory affairs and eCTD publishing. PhACT supports all pre- and post-approval registration projects within the European Union and/or Switzerland and supports eCTD submission projects worldwide.
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About us - PhACT GmbH – Regulatory Affairs Consulting
http://www.jentges.com/about-us
Strategy. Solution. Submission. PhACT, a Swiss-based company, is the abbreviation for 'Pharmaceutical Advice, Compliance and Training’ specialized in drug regulatory affairs’ and was founded November 2006. There are risks and costs to a program of action. But they are far less than the long range risks and costs. John F. Kennedy. 2015 PhACT GmbH Disclaimer.
e-Submission - PhACT GmbH – Regulatory Affairs Consulting
http://www.jentges.com/e-submission
Strategy. Solution. Submission. With electronic submissions (e-submissions) following the internationally standardized Common Technical Document (eCTD) specification, the transfer of regulatory submissions from applicant to regulators has changed from paper to digital worldwide. The specification for the eCTD is based on Extensible Markup Language (XML) technology and lists the criteria that make an e-submission technically valid. 2015 PhACT GmbH Disclaimer.
Project Management - PhACT GmbH – Regulatory Affairs Consulting
http://www.jentges.com/project-management
Strategy. Solution. Submission. A number of internal and external stakeholders are involved in a submission project such as clinical research organizations, medical writers, consultants. All their activities need to be coordinated in terms of results and timing. PhACT supports its clients with professional project management. Failing to plan,. Is planning to fail. 2015 PhACT GmbH Disclaimer.
Publications - PhACT GmbH – Regulatory Affairs Consulting
http://www.jentges.com/publications.html
Strategy. Solution. Submission. Pharmaceutical Legislation of the European Union, Japan and the United States of American An Overview by Dr. Barbara Jentges, Nobuo Tateishi, Kate Denton and Dr. Dr. Michel Mikhail. The Pharmaceutical Legislation of the European Union, Japan and the United States of America An Overview gives an overview of the pharmaceutical legislation of the three ICH regions through chapters on Regulatory Bodies and Health Authorities: Functions and Responsibilities, Pharmaceutical Legi...
Disclaimer - PhACT GmbH – Regulatory Affairs Consulting
http://www.jentges.com/disclaimer.html
Strategy. Solution. Submission. Welcome to the PhACT website which informs you about the company profile and the regulatory services provided. PhACT will use reasonable efforts to provide up-to-date and accurate information on and via this website. However, information on this website is not to be construed as binding and current and accurate information is not guaranteed. Links to Third-Party Websites. This disclaimer is subject to Swiss laws and shall be construed in accordance with these regulations.
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PhACT GmbH – Regulatory Affairs Consulting - Home
Strategy. Solution. Submission. 41 61 751 78 75. 41 61 751 78 76. PhACT is an independent consultancy specialized in European drug regulatory affairs and eCTD publishing. PhACT supports all pre- and post-approval registration projects within the European Union and/or Switzerland and supports eCTD submission projects worldwide. 2018 PhACT GmbH Disclaimer.
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