Regulatory Consulting & Strategy

CBR Biotech Strategies GmbH offers many services tailored to the pharmaceutical and medical device industries.

gmpOur service offerings include:
  • Assist with the preparation of EMA, national competent authority, and FDA submissions (both paper and electronic)
  • Act as the U.S. Agent for U.S. INDs, NDAs and BLAs for non-U.S. companies
  • Act as Legal Representative to European Agencies, for non-European companies
  • Develop and file CTAs and IMPDs
  • Conduct face-to-face and teleconferences with regulatory agencies
  • Analytical method development and validation consulting
  • GMP consulting and auditing services
  • Clinical trial auditing and CRO oversight
  • Medical writing and strategic clinical design services
  • Nonclinical study design and CRO assessments
  • QP services (QPPV and/or Quality)
  • SUSAR reporting
  • EUDRACT registrations
  • eCTD publishing