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	Sitemap GoogleSiteMap_EN Overview Drug Regulatory Affairs Company About us Vision Mission Facts and figures Organisation Partners Reasons to choose YES Directions The way to YES Friedrichsdorf The way to YES Karlsruhe The way to YES Austria Careers Your skills What we have to offer Job vacancies Freelancer AMNOG Part-time Assistant in Pharmacovigilance in Friedrichsdorf Physician, pharmacist or natural scientist as Medical Advisor in Friedrichsdorf Project Management / Back Office Assistant in Friedrichsdorf Intern or working student Human Resources in Friedrichsdorf Assistant for Medicine & Toxicology (Part-time/Full-time) Functional Head of Pharmacovigilance in Friedrichsdorf Freelancer Advisor Regulatory Affairs/Quality Management for medical devices in Friedrichsdorf We train! Management assistant for office communication in Friedrichsdorf Expertise Our employees (a selection) Dr. Annemie Bils Dr. Thomas Dobmeyer Dr. Rainer Canenbley Dr. Axel Nolting Dr. Karin Lübbers Dr. Markus Zimmer Hannelore Bambach Dr. Thomas Schöpke Florian Tolkmitt Dr. Jürgen Hönig Dr. Cornelia Tutsch Dr. Raphael Troost Dr. Thomas Eberwein Viola Hoffmann Mag. Ursula Moser Publications Lectures 2009 2010 YES platforms Vigilit Vigicare Read-a-PIL Outsourcing Our understanding of outsourcing Business Process Outsourcing Outtasking News Challenges and Approaches Christmas Donation to Bärenherz Pharmind issue 08/11 YES supports the association „Red Noses Clowndoctors“ YES at the Euro-Meeting The British government agency MHRA inspects YES Medicinal products Consulting New product developments Development plans Project implementation Product and portfolio analysis Regulatory strategies Emerging Markets Pharmaceutical quality Preclinical phase Clinical phase e-regulatory affairs Medicinal product safety Quality management Training Veterinary products National activities YES in Austria Development Discussions with the regulatory authorities Early development phase Coordination and support Pharmaceutical Quality Preclinical development Clinical development Document management Administrative documents Pharmaceutical quality Preclinical phase Clinical phase Emerging Markets Veterinary products National activities YES in Austria Marketing authorisation Dossier management IMPD/eIMPD CTD eCTD NeeS Marketing authorisation procedures Recognition procedures National procedures Decentralised procedures Centralised procedure Process management Coordination Communication with the regulatory authorities Dealing with questions raised by the regulatory authorities (response documents) Referrals and arbitrations Granting of marketing authorisation Liaison with the regulatory authorities Product information Linguistic review PIM Labelling Readability tests Emerging Markets Veterinary products National activities YES in Austria eCTD Maintenance Variations Updating quality documentation Renewal Compliance National follow-up measures Emerging Markets Local support Austria, Amendment to the Medicinal Products Act Summary of product characteristics Extensions Veterinary products National activities YES in Austria Drug safety Overall responsibility Case management Literature surveillance PSUR writing Risk management plans Graduated plan procedure Risk-benefit assessment Development phase QM & compliance services Auditing DDPS Peri-inspection services Implementation and optimisation Contract management SOP training and workshops Medical devices Consulting Training Directive 2007/47/EC Development support CE marking & intl authorisation Document compilation Maintenance Post-market surveillance Unser Service Lorem ipsum dolor sit amet consequer adipiscing nihil lit nonnumy eram lorem ipsum dolor sit amet nihil elit consequer erat. ispum dolor sit amet conseuqer spum. Lorem ipsum mehr
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