• Design of an integrated CMC development plan addressing the strategic
    and technical aspects of chemical and pharmaceutical development

API development

  • Physicochemical characterization and structure elucidation
  • Sourcing of starting materials, intermediates and API
  • Chemical process development, upscaling and GMP synthesis
  • Analytical methods development and validation
  • Stability study design and evaluation

Formulation development

  • Preformulation development
  • Formulation development according to ICH Q9 QbD using DoEs
  • Supply of IMP for pivotal preclinical studies
  • Packaging and labeling for international clinical trials

Analytical development

  • Analytical methods development and validation
  • Stability study design and evaluation

Process development

  • Manufacturing process development according to ICH Q9 QbD using DoEs
  • Upscaling and GMP production
  • Process optimization and validation

Risk management

  • Risk analysis
  • Mitigation plan
  • FMEA
  • CMO and CRO selection and management

CMC regulatory affairs

  • Determine the relevant CMC regulatory strategy and assure the quality, consistency and technical validity of CMC regulatory documentation
  • Conduct external GMP audits of API and IMP manufacturers
  • Preparation for FDA readiness
  • Participation on audits by regulatory authorities (local and FDA)
  • Preparation of and attendance at meetings with regulatory agencies
  • Compilation of IMPD / IND for Clinical Trial Applications
  • Compilation of Dossier Module 3
  • Evaluation of CMC documentation for due diligences

Quality assurance management

  • Quality Assurance strategy and regulatory compliance for development projects
  • Set up and maintain the Quality Management System
  • Quality Risk Management [ICHQ9]
  • Compilation of quality assurance agreements
  • Deviation and Change Control Management
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