Building the bridge to success
Bringing innovative science to clinical development stage
by bridging the Chemistry, Manufacturing, and Controls gap
Why CMC matters
CMC as the interface between innovative science, early development, production at scale, regulatory compliance and robust supply chain
Helos‘ CMC Leadership for Radiopharmaceutical and Pharmaceutical Innovation
Johannes Nagel, PhD, (Founder and CMC Consultant) is a senior CMC leader with 10+ years of specialized expertise in (radio-)pharmaceutical development across the full product lifecycle—from early-stage research through commercial readiness.
Core Competencies and Technical Expertise
End-to-end CMC strategy development and execution from preclinical through commercial stages. Module 3 authoring for IND, IMPD, BLA, and MAA submissions. Process development, characterization, and validation. Analytical method development and validation per ICH guidelines. Quality target product profile (QTPP) definition and control strategy implementation.
EU and US GMP compliance. Equipment qualification (IQ/OQ/PQ). Process validation and continued process verification. Deviation investigation and CAPA implementation. Quality risk management (ICH Q9). Change control and comparability protocols. Supplier qualification and management.
Direct experience with EMA, FDA, and DKMA interactions. IND/IMPD/BLA/MAA submission experience. Pre-IND meetings and scientific advice procedures. Responding to regulatory deficiency letters and information requests. CMC-related inspection readiness and management. Regulatory intelligence and landscape monitoring.
Partner identification, assessment, and qualification. Quality agreement and technical transfer negotiations. Multi-site coordination across EU and US. Audit planning and execution.
Performance monitoring and relationship management. Supply chain risk mitigation strategies.
Integrated project planning and scheduling. Critical path analysis and mitigation strategies. Budget development and tracking. Risk identification, assessment, and mitigation. Issue escalation and resolution. Performance metrics and KPI development.
Our Services
Operational Services
Multi-isotope platforms
Formulation optimization
Stability studies
Chelator design
Process characterization
EU and US compliance
CMO parter selection & management
Process validation
Equipment qualification
Quality risk management
Process descriptions and Module 3 documentation
Specifications & procedures
Validation reports
Comparability protocols
Quality and supply agreements
Strategic Services
Chemistry validation
Manufacturing readiness assessment
Regulatory pathway analysis
Go / No-go criteria
Risk quantification
Integrated CMC roadmaps
Technology transfer strategy
Quality by Design framework and control strategy
Budget forecasting
CMO capability assessments (EU/US)
Process characterization and validation strategy
Supply chain risk mitigation
Regulatory compliance
Helos Life Science Consulting
Your Partner for CMC strategies
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