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PhACT GmbH

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http://www.phact.ch/

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PhACT GmbH | phact.ch Reviews
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Phact Shop.
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1 Quality
2 Regulatory
3 Training
4 Regulatory Affairs
5 Quality Management
6 Compliance
7 Consulting
8 Pharmaceutical
9 Drug Products
10 Medicinal Products
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phact shop,find more,toggle navigation,phact,team,credo,publications,news,partners,quality and gmp,inspection preparation,auditing,pharmaceutical quality systems,quality risk management,knowledge management,data integrity,documentation optimization,public
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PhACT GmbH | phact.ch Reviews

https://phact.ch

Phact Shop.

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1

Project Management - PhACT GmbH – Regulatory Affairs Consulting

https://www.phact.ch/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.

2

About us - PhACT GmbH – Regulatory Affairs Consulting

https://www.phact.ch/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.

3

Regulatory Services - PhACT GmbH – Regulatory Affairs Consulting

https://www.phact.ch/regulatory-services

Strategy. Solution. Submission. PhACT provides professional regulatory advice and supports its clients in all fields related to marketing authorisation applications such as. New or abbreviated marketing authorisation application, following either the centralised (CP), decentralised (MRP, DCP) or national procedure. Variation application (type IA/IB, type II, extension). Application for a Certificate of Suitability (CEP). Active substance master files (ASMF) procedure. Any other regulatory support needed?

4

Publications - PhACT GmbH – Regulatory Affairs Consulting

https://www.phact.ch/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...

5

e-Submission - PhACT GmbH – Regulatory Affairs Consulting

https://www.phact.ch/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.

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jentges.com jentges.com

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...

jentges.com jentges.com

Impressum - PhACT GmbH – Regulatory Affairs Consulting

http://www.jentges.com/impressum.html

Strategy. Solution. Submission. 2015 PhACT GmbH Disclaimer.

jentges.com jentges.com

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.

jentges.com jentges.com

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.

jentges.com jentges.com

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.

jentges.com jentges.com

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.

jentges.com jentges.com

Regulatory Services - PhACT GmbH – Regulatory Affairs Consulting

http://www.jentges.com/regulatory-services

Strategy. Solution. Submission. PhACT provides professional regulatory advice and supports its clients in all fields related to marketing authorisation applications such as. New or abbreviated marketing authorisation application, following either the centralised (CP), decentralised (MRP, DCP) or national procedure. Variation application (type IA/IB, type II, extension). Application for a Certificate of Suitability (CEP). Active substance master files (ASMF) procedure. Any other regulatory support needed?

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PhACT GmbH

Skip to main content. Responsible Person (Swiss QP). Quality by Design (QbD). Post Approval Change Management. General Terms and Conditions. Responsible Person (Swiss QP). Quality by Design (QbD). Post Approval Change Management. General Terms and Conditions. Pharmaceutical Advice, Compliance and Training (PhACT). Advice. Compliance. Training. Advice. Compliance. Training.

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PHACT: Polymer Hot And Cold Technology association

Blue Ocean Southern Africa. PHACT Association is a national body to represent the interests of manufacturers and distributors of Polymer piping systems for hot and cold water applications and to deal with each and all such matters as may affect the common interests of the members and the industry. Another successful Spider Web Creations.

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Phact (A Firefly) - DeviantArt

Window.devicePixelRatio*screen.width 'x' window.devicePixelRatio*screen.height) :(screen.width 'x' screen.height) " class="mi". Window.devicePixelRatio*screen.width 'x' window.devicePixelRatio*screen.height) :(screen.width 'x' screen.height) ". Join DeviantArt for FREE. Forgot Password or Username? Deviant for 10 Years. This deviant's full pageview. Last Visit: 15 weeks ago. This is the place where you can personalize your profile! By moving, adding and personalizing widgets. Why," you ask? April 1, 2010.

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PHACT - Software gestionale gratuito per 30 giorni

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