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Consulting Services in Drug Regulatory Affairs

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CONTACTS AT KINTZEL-REGULATORY.COM

Regulatory Affairs Services Dr. Kintzel Freiberufler

Birge●●●●●ntzel

Falke●●●●●so 21

Fal●●●see , 14612

GERMANY

4933●●●●8892
bi●●●●●●●●●●●●@web.de

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Birger Kintzel

Falke●●●●●so 21

Fal●●●see , 14612

GERMANY

4933●●●●8892
bi●●●●●●●●●●●●@web.de

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Consulting Services in Drug Regulatory Affairs
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Services

http://www.kintzel-regulatory.com/services.html

Contracting – home based or at c. Preparing and submitting CTAs and. RA lead function in regional / global development projects. Preparing Regulatory Strategy documents a. Nd leading Scientific Advice meetings with Regulatory authorities. Regulatory maintenance work – variations, line extensions, renewals, PSURs. CMC dossier writing and support incl. project transfer duties. Alignment of Product Information with CCDS and other Labelling tasks. Providing training in Regulatory Affairs to company staff.

2

Profile

http://www.kintzel-regulatory.com/profile.html

1993-1994: RA Manager at Janssen-Cilag GmbH (Neuss, Germany). 1994-1999: Head of RA at Synthelabo Arzneimittel GmbH (Munich/Berlin, Germany). 1999-2003: Head of RA and Health Outcomes at Pharmacia GmbH (Erlangen, Germany). Enior Director EU RA at Elan Pharma Ltd (Stevenage, Herts, UK). 2005-2008: Global RA Director at Baxter Worldtrade (Brussels, Belgium and Maurepas, France). Independent RA consultant since 2008.

3

Imprint

http://www.kintzel-regulatory.com/imprint.html

Regulatory Affairs Services Dr. Kintzel. Dr rer. nat. Dipl.-Pharm. Birger Kintzel. Mobile: 49-162-18 89 512. VAT ID No. DE 264656437. Responsible for content of this site: Dr. Birger Kintzel. Portrait photos: Photographic studios Heinemann Falkensee and Inga Haar Berlin.

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Regulatory Affairs Services Dr. Kintzel. Serving the Pharmaceutical Industry since 2008. Are you looking for an experienced Regulatory Affairs professional who can provide a broad range of Regulatory Affairs Services? Feel free to explore details of my professional profile, the services that I might be offering to you as well as information on current and previous assignments on the next pages. Consultant to the pharmaceutical industry since 2008.

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