_Life Science & Health Care 

_Consulting

_Quality Management & Auditing

_Regulatory Compliance

_R&D / Toxicology

_Qualification & Validation

_Projckt Management

REGULATORY COMPLIANCE
R&D / TOXICOLOGY

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)

    “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.”

    Christina Piskernik
    Senior Consultant Regulatory Compliance, Toxikologie und R&D

    YOUR QUESTIONS?

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

    I have got a question,

    please contact me

    T. +43-(0)1 79 80 334
    E. 

    I wish personal consultation

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    COMPANY

    SERVICES

    CAREERS

    CONTACT

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

    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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