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IDRAS - Welcome to the i.DRAS GmbH websitei.DRAS stands for international, intelligent, individual, innovative and independent solutions for your drug regulatory affairs projects
http://www.in-kam.com/
i.DRAS stands for international, intelligent, individual, innovative and independent solutions for your drug regulatory affairs projects
http://www.in-kam.com/
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i.DRAS GmbH i.G
Markus Veit
Fraunh●●●●●●r. 18b
Pl●●gg , 82152
DE
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i.DRAS GmbH i.G
Markus Veit
Fraunh●●●●●●r. 18b
Pl●●gg , 82152
DE
View this contact
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IDRAS - Welcome to the i.DRAS GmbH website | in-kam.com Reviews
https://in-kam.com
i.DRAS stands for international, intelligent, individual, innovative and independent solutions for your drug regulatory affairs projects
in-kam.com
IDRAS - Downloads
http://www.in-kam.com/downloads_64.html
CV Dr med. Christian Schübel (engl.). CV Dr Andrea Klüting (engl.). CV Andrea Klüting (engl.). Curriculum vitae Prof. Dr. Markus Veit. Idras Flyer engl. (PDF 747 KB). CV Prof. Dr. Hildegard Sourgens (engl.). Middot; Fraunhoferstraße 18b · D-82152 Planegg / Martinsried.
IDRAS - Willkommen auf den Webseiten der i.DRAS GmbH
http://www.in-kam.com/home_3.html
Willkommen auf den Webseiten der i.DRAS GmbH. DRAS steht für i. Ntelligente Lösungen für Ihr Entwicklungs-, Registrierungs- und Zulassungsprojekt. Middot; Fraunhoferstraße 18b · D-82152 Planegg / Martinsried.
IDRAS - clinical development
http://www.in-kam.com/clinical-development_58.html
Overview of service spectrum. Marketing authorisation and certification. Comprehensive services on pharmaceutical development via our partner Sercona. Assurance of GMP compliance of the drug substances for clinical trials via our partner Sercona. Manufacture of investigational medicinal products via our partner Sercona. Monitoring and planning of scale-up processes via our partner Sercona. Writing and revision of reports and GMP documentation. CTA compilation and submission.
IDRAS - marketing authorisation and certification
http://www.in-kam.com/marketing-authorisation-and-certification_59.html
Overview of service spectrum. Marketing authorisation and certification. Marketing authorisation and certification. Support and project management in marketing authorisation and certification procedures. Compilation, revision and assessment of dossiers in the CTD and NtA format (veterinary medicinal products) for different marketing authorisation procedures. Technical translations English-German / German-English. Planning and supervision of method and site transfers. Compilation of documentations on the ...
IDRAS - glossary
http://www.in-kam.com/glossary_63.html
API Active Pharmaceutical Ingredient. ASMF Active Substance Master File. CDA Confidential Disclosure Agreement. CEP Certificate of Suitability to the Monograph of the European Pharmacopoeia. CMC Chemistry - Manufacture - Control. CTD Common Technical Document. DMF Drug Master File. DRA Drug Regulatory Affairs. EDMF European Drug Master File. FDA Food and Drug Administration. GLP Good Laboratory Practice. GMP Good Manufacturing Practice. ICH International Conference of Harmonisation.
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IDRAS - Welcome to the i.DRAS GmbH website
Overview of service spectrum. Marketing authorisation and certification. Welcome to the i.DRAS GmbH website. DRAS stands for i. Ntelligent solutions for your development, registration and marketing authorisation project. Middot; Fraunhoferstraße 18b · D-82152 Planegg / Martinsried.
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