• 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
  • Upscaling and GMP synthesis
  • Chemical process development - from QbD to Process Validation [ICH Q11]
  • Stability study design and evaluation

Formulation development

  • Preformulation development
  • Formulation development according to ICH Q8 QbD using DoEs
  • Supply of medication for pivotal preclinical studies
  • Packaging labeling of IMP and supply for international clinical trials using IRS according to GDP requirements

Analytical development

  • Analytical methods development and validation for drug substance and drug product
  • Process Analytical Technology (PAT)

Process development

  • Upscaling and GMP production
  • Manufacturing process development and launch of a QbD process [ICH Q8]
  • Process validation and post approval change management
  • Stability study design and evaluation
  • 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
  • Preparation of and attendance at meetings with regulatory agencies
  • Compilation of IMPD / IND for international Clinical Trial Applications Phase I - III
  • Compilation of Dossier Module 3 for MAA/NRA to FDA, EMA, ANVISA, WHO Article 58
  • 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
  • Qualification of external supplier including conduction of 3rd party audits of CMOs, and analytical labs
  • Preparation for FDA and EMA inspection and conduction of pre-site inspections
  • Participation on audits by regulatory authorities (local and FDA)
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