Regulatory Compliance R D / Toxicology en

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DEUTSCH

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ENGLISH

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_Life Science & Health Care

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” content_last_edited=”on|phone” _builder_version=”4.14.4″ _module_preset=”default” text_font=”Source Sans Pro||||||||” text_text_color=”#288bcb” text_font_size=”18px” header_text_color=”#FFFFFF” background_color=”#FFFFFF” width=”300px” custom_margin=”-6px|195px|5px||false|false” custom_padding=”|10px|||false|false” link_option_url=”/index.php/home-en/life-science-health-care-consulting-en/” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]

_Consulting

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_Quality Management & Auditing

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_Regulatory Compliance

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_R&D / Toxicology

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_Qualification & Validation

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_Project Management

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REGULATORY COMPLIANCE
R&D / TOXICOLOGY

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Regulatory Support

Regulatory documents and applications for global submissions
Non-clinical and CMC sections (module 2, module 3,
module 4)
Preparation in electronic common technical document (eCTD) format
Addressing of issues raised by regulatory agencies (deficiency letters)
Support in document life cycle management

Toxicology

Regulatory toxicology
Toxicological risk assessments
Literature research

R&D

Support in preclinical development
Interim management of R&D and GLP sites and laboratories
Document management (drafting, administration and archiving of SOPs)

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“Mutual esteem, empowerment, and working as a partnership of equals: when collaborating with our clients it’s the human touch that raises the outcome to the next level.”

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Christina Piskernik

Senior Consultant Regulatory Compliance, Toxikologie und R&D

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YOUR QUESTIONS?

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If you have any questions regarding our services or wish personal consultation, do not hesitate to contact us.

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I have got a question,

please contact me

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T. +43-(0)1 79 80 334
E. office@inosolve.com

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I wish personal consultation

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COMPANY

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SERVICES

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CAREERS

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CONTACT

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INOSOLVE CONSULTING SERVICE & ENGINEERING GESMBH
Leopold-Boehm-Str. 12 / D65,
1030 Vienna, Austria
T. +43-(0)1 79 80 334
E. office@inosolve.com

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INOSOLVE CONSULTING GMBH
Kranhaus 1, Im Zollhafen 18
50678 Köln, Germany
T. +49 (0) 221 65060-504
E. officeicd@inosolve.com

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INOSOLVE PHARMACEUTICAL & HEALTH CONSULTANCIES
Avenue Building, Floor 4, 4B-02 Port Saeed, Diera Dubai, UAE
T. +971 (0) 50 3010548
E. ahmed.yahya@inosolve.com

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Deutsch

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English

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Imprint

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Datenschutz

” content_phone=”

Datenschutz

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____Data privacy

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