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)