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Herzlich willkommen!Of Dr Irene Gander-Meisterernst.
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Regualtory Strategies
Irene Gander-Meisterernst
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Mue●●●ter , 48149
GERMANY
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Regualtory Strategies
Irene Gander-Meisterernst
Schu●●●●. 10
Mue●●●ter , 48149
GERMANY
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Neue Medien Muennich GmbH
Werner Kaltofen
Haup●●●●. 68
Frie●●●●dorf , 02742
GERMANY
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Neue Medien Muennich GmbH
Werner Kaltofen
Haup●●●●. 68
Frie●●●●dorf , 02742
GERMANY
View this contact
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Herzlich willkommen! | regulatory-strategies.com Reviews
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Of Dr Irene Gander-Meisterernst.
regulatory-strategies.com
Imprint
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Tel: ( 49) 0176 272 676 08. Responsible ( 55 Abs. 2 RStV9): Dr. Irene Gander-Meisterernst. Trotz sorgfältiger inhaltlicher Kontrolle übernehmen wir keine Haftung für die Inhalte externer Links. Für den Inhalt der verlinkten Seiten sind ausschließlich deren Betreiber verantwortlich. Einsatz von Google Analytics. Von Google Analytics verwenden, sofern es für Ihren Browser verfügbar ist. Erstellt mit der Freeware-Version von Zeta Producer CMS, nur für den privaten Gebrauch.
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Of Dr Irene Gander-Meisterernst.
Partners
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Granzer Regulatory Consulting and Services. Quality x Pharma Consulting GmbH. Quality Consultant, QA Services to pharma/biotech companies to comply with EU regulations. D - 82319 Starnberg. Widler and Schiemann AG, Clinical Quality Management. CH - 6300 Zug. Http:/ www.wsqms.com. Hecker and Associates (US).
Experience
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Development of small molecules, biopharmaceuticals, herbal drugs. And Advanced Therapy Medicinal Products. Therapeutic areas: oncology, dermatology, cardiology, infectious disease,. Scientific advice procedures with German, French, Austrian, Swedish. And Spanish agencies as well as with FDA. Clinical trial applications EU. EU and US development and filing strategies. European and US Marketing Authorization procedures. Regulatory consultant since 2008. New York, US.
Services
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Should you have reached important milestones with your project, e.g. preparing for. Entry into clinical development or entering into phase III development, I can help you. With my expertise to elaborate a successful global meeting strategy for scientific advice. And the required documentation. Are you preparing for MAA or NDA submissions? I generate with you the required summary. And regulatory documentation for submission or give you and outside view for consistency. To FDA and to Health Canada.
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Regulatory Risk Management — Analysis of regulatory risk in Financial Markets
August 13, 2015. Systemic risk in financial markets. Introduction The International Monetary Fund ( IMF ) summarises causes of the global financial crisis within three dimensions: Flaws in financial regulation and supervision . Failure of monetary policy to address the build-up of systemic risk. Weak global financial architecture . Set out below is a breakdown and analysis of these three dimensions and a close inspection of systemic […]. Basel III a reality. Basel III and liquidity management in banks.
Regulatory Service
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Staff, Strategies, and Solutions for Nuclear Plant Licensing. The mission of RTS is to replace the mystery in regulatory affairs with certainty, leverage the use of precedents, and establish predictability based on lessons learned. 45; Keith Graham, President. Photos courtesy of Nuclear Energy Institute. We make Nuclear Regulatory Affairs PREDICTABLE. The RTS team members can:. Advise your team what to expect from regulators. Advise what regulators expect from your team. NRC Resident and Team Inspections.
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regulatory-writing-resources.com
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Grogan | Medical Writing & Consulting
Where Language Meets Science. One of the largest challenges, which a pharmaceutical company encounters, is faced during the few months preceding a MAA submission or a significant drug development undertaking. With often millions in resources invested up until this period, it is imperative that the health authorities are presented with documentation that is accurate, clear and concise, besides meeting regulatory requirements. Not all companies have the resources in-house to meet this special challenge.
Bickmore Regulatory Consulting - Home
Phone: 800.541.4591 / Fax: 916.244.1199. 1750 Creekside Oaks Drive, Suite 200 / Sacramento, CA 95833. Group Self-Insurance: Monitoring, Benchmarking, and Best Practices. Group self-insurance can represent major savings to employers; however group self-insurers should be closely monitored by states. Rarr; read more. Assisting departments of insurance with reviews of rate filings. Rarr; read more. Employers and Employee Representatives. Rarr; read more. Workers’ Compensation Report Card. Rarr; read more.
