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, Toxicology and R&D

Your Questions?

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

T. +43-(0)1 79 80 334
E.