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