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