Principal Consultant

Christian Redondo-Müller

Christian has been with NDA since 2008, with over 25 years of global clinical & regulatory experience. He applies his detailed knowledge of legislation, guidance and procedures to successfully support companies throughout their clinical development and the complex EU and US MAA/NDA/BLA marketing authorisation procedures.

Key Areas Of Expertise
  • Comprehensive knowledge of regulatory requirements and procedures (NDA, MAA, CTA, PIP, ODD, scientific advice).
  • Broad regulatory affairs experience in supporting early to late-stage clinical development with a focus on clinical development strategy, efficacy, safety and benefit/risk assessments
  • Track record of successful co-ordination of the operational execution of clinical modules for EU submissions as part of complex multidisciplinary teams
  • Evaluation of clinical packages for chances of success in EU regulatory reviews
  • Track record of successfully advising and leading clients teams in the generation of response documents during major EU submissions
  • Inception, coordination and content review of clinical regulatory documents e.g. IB, IMPD, CTD, Briefing packages, modules 2.5 , 2.7.3 and 2.7.4 for global regulatory dossiers
Before NDA

Christian spent 10+ years in the pharmaceutical industry in roles of increasing responsibility in regulatory affairs, drug safety and R&D Project Management, formerly the head of project management for a European therapeutic business unit of a global pharmaceutical company.

Christian Redondo-Müller

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