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Drug Regulatory Fees Calculator. Is the change really worth it? What budget do I have to reserve for registering my variations? Is it financially more attractive to use a DCP rather than a CP? How do fees compare for countries acting as a reference member state in a mutual recognition procedure? We provide the following information:. The calculator covers the EEA. The following regulatory activities are covered: MAAs, Variations, Renewals, Line Extensions. Interested in an RA position in Berlin? Please s...

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Drug Regulatory Fees Calculator. Is the change really worth it? What budget do I have to reserve for registering my variations? Is it financially more attractive to use a DCP rather than a CP? How do fees compare for countries acting as a reference member state in a mutual recognition procedure? We provide the following information:. The calculator covers the EEA. The following regulatory activities are covered: MAAs, Variations, Renewals, Line Extensions. Interested in an RA position in Berlin? Please s...

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Home - Regfee calculator | regulatory-fees.eu Reviews

https://regulatory-fees.eu

Drug Regulatory Fees Calculator. Is the change really worth it? What budget do I have to reserve for registering my variations? Is it financially more attractive to use a DCP rather than a CP? How do fees compare for countries acting as a reference member state in a mutual recognition procedure? We provide the following information:. The calculator covers the EEA. The following regulatory activities are covered: MAAs, Variations, Renewals, Line Extensions. Interested in an RA position in Berlin? Please s...

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regulatory-fees.eu

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calculator - Regfee calculator

http://www.regulatory-fees.eu/calculator

Select from activities such as initial marketing authorisations, renewals, line extensions or variations. Please select an activity. Referrals (acc 6.1 658/2014). The types of marketing authorisation are classified according to the EU directive 2001/83/EC. Procedures can be selected from national, decentralised (DCP), mutual recognition (MRP) and centralised. Concerned member state (multiple selection possible). Please click twice to activate selection of CMS country.

2

partners - Regfee calculator

http://www.regulatory-fees.eu/partners

This regulatory fee calculator is sponsored by:. More about our sponsors. The German Pharmaceutical Industry Association (BPI) represents the full spectrum of activities of the pharmaceutical industry on both a national and international level. The BPI consists of approximately 240 pharmaceutical companies with about 70.0000 employees. In case you consider supporting our work please contact almut.holz[at]xendo.com. You will also find further information in the FAQ.

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Imprint - Regfee calculator

http://www.regulatory-fees.eu/imprint

Rankestraße 1 / Kurfürstendamm 237. Local Court of Charlottenburg. HRB (Commercial Register) no. 121013B. Persons responsible for the content pursuant to Section 55 of the Interstate Broadcasting Agreement (RStV):. Dr Robert Schultz-Heienbrok (Managing Director). Technical Development and Design. Legal effect of this liability disclaimer. Note: For ease of reading, the masculine form has been used in the text to refer to both genders.

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FAQ - Regfee calculator

http://www.regulatory-fees.eu/faq

Can you guarantee the accuracy of the data? Where do you source the information? We screen the homepages of the authorities biweekly. Links to the source documents are published here. Do you charge for the service? The service is offered free of charge. I have never heard of Xendo Deutschland GmbH. What is your business? Xendo Deutschland is the German 100% subsidiary of the Dutch pharmaceutical consultancy Xendo B.V. My company likes to sponsor the project how does it work? Thanks for considering suppor...

5

Services - Regfee calculator

http://www.regulatory-fees.eu/services

The fee calculator is provided by Xendo Deutschland GmbH. Over 2,000 data sets cover fees for a wide range of regulatory activities. However there is scope for more:. The data could be expanded to special regions in the world. Document requirements and/or conditions for regulatory submissions could be included. Veterinary data could be covered. Regulatory activities such as Clinical Trial Applications and Scientific Advice could be added. We design, build and maintain databases that suit your needs.

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xendo.com

Xendo - Willkommen auf der Xendo Webseite

http://www.xendo.com/du-401/home.htm

Engineering and technical support. Xendo hebt Maintenance Management auf andere Level. Willkommen auf der Xendo Webseite. Xendo ist ein führendes, unabhängiges Unternehmen für Beratung und Projektmanagement in den Bereichen Life Sciences, Arzneimittel und Gesundheitswesen. Wir werden Sie bei der Verbesserung der Qualität und Sicherheit von Medikamenten sowie bei der Beschleunigung des Markteintritts unterstützen. Launch of the Regfee calculator. Here is the link to the calculator:. In your company you&rs...

xendo.info

Xendo - Willkommen auf der Xendo Webseite

http://www.xendo.info/du-401/home.htm

Engineering and technical support. Xendo hebt Maintenance Management auf andere Level. Willkommen auf der Xendo Webseite. Xendo ist ein führendes, unabhängiges Unternehmen für Beratung und Projektmanagement in den Bereichen Life Sciences, Arzneimittel und Gesundheitswesen. Wir werden Sie bei der Verbesserung der Qualität und Sicherheit von Medikamenten sowie bei der Beschleunigung des Markteintritts unterstützen. Launch of the Regfee calculator. Here is the link to the calculator:. In your company you&rs...

xendo.nl

Xendo - Willkommen auf der Xendo Webseite

http://www.xendo.nl/du-401/home.htm

Engineering and technical support. Xendo hebt Maintenance Management auf andere Level. Willkommen auf der Xendo Webseite. Xendo ist ein führendes, unabhängiges Unternehmen für Beratung und Projektmanagement in den Bereichen Life Sciences, Arzneimittel und Gesundheitswesen. Wir werden Sie bei der Verbesserung der Qualität und Sicherheit von Medikamenten sowie bei der Beschleunigung des Markteintritts unterstützen. Launch of the Regfee calculator. Here is the link to the calculator:. In your company you&rs...

xendo-de.com

Xendo Deutschland- RA Tools

http://www.xendo-de.com/en-662/ra-tools.htm

Regulatory Procedures and Strategy. Regulatory Procedures and Strategy. The daily business of regulatory professionals involves processing of different information from various sources. Today`s complex, validated IT solutions are usually not flexible enough to keep pace with the ever changing regulatory environment and the need for on-the-spot information. We build RA intelligence tools based on our day-to-day work experience. Our RA consultants translate specific tasks into versatile solutions.

xendo-de.com

Xendo Deutschland- History

http://www.xendo-de.com/en-648/history.htm

Regulatory Procedures and Strategy. Xendo B.V., Netherlands was founded in 1990 as a pharmaceutical service company. Xendo Deutschland was founded in 2009. Foundation. Offering services in Regulatory Affairs for pharmaceutical and biopharmaceutical products. Set-up of eCTD services. Set-up of a SharePoint solution as a Regulatory Affairs management server. Launch of the RegFee. Calculator in cooperation with the BPI (the German association of pharmaceutical industry). Again in cooperation with the BPI.

bpi.de

BPI - Partner im Gesundheitswesen: Nachrichten

http://www.bpi.de/home

Pharmazeutischen Industrie e.V. BPI-Stellungnahmen / BPI-Synopsen / BPI-Gutachten. BPI-Stellungnahmen / BPI-Synopsen / BPI-Gutachten. Ein Magazin über Krankheit, Versorgung und Geschäft. LEITFADEN - Versorgungs- forschungsstudien. LEITFADEN - zur Planung von Versorgungs- forschungsstudien in Pharmazeutischen Unternehmen. Der Newsletter der pharmazeutischen Industrie. Die Pharma-Argumente: Gute Gründe für Arzneimittel (und deren Hersteller). Lesen Sie hier weiter. Pressemitteilung vom 04.08.2016. Das Bund...

bpi.de

BPI - Partner im Gesundheitswesen: Nachrichten

http://www.bpi.de/home/nachrichten/nachrichten?tx_ttnews[pointer]=1

Pharmazeutischen Industrie e.V. BPI-Stellungnahmen / BPI-Synopsen / BPI-Gutachten. BPI-Stellungnahmen / BPI-Synopsen / BPI-Gutachten. Ein Magazin über Krankheit, Versorgung und Geschäft. LEITFADEN - Versorgungs- forschungsstudien. LEITFADEN - zur Planung von Versorgungs- forschungsstudien in Pharmazeutischen Unternehmen. Der Newsletter der pharmazeutischen Industrie. Die Pharma-Argumente: Gute Gründe für Arzneimittel (und deren Hersteller). Lesen Sie hier weiter. Pressemitteilung vom 21.06.2016. Deutsche...

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regulatory-fees.eu

Home - Regfee calculator

Drug Regulatory Fees Calculator. Is the change really worth it? What budget do I have to reserve for registering my variations? Is it financially more attractive to use a DCP rather than a CP? How do fees compare for countries acting as a reference member state in a mutual recognition procedure? We provide the following information:. The calculator covers the EEA. The following regulatory activities are covered: MAAs, Variations, Renewals, Line Extensions. Interested in an RA position in Berlin? Please s...

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