Preparation of integrated development plans with tailored regulatory strategy

  • Target product profile definition
  • Integrated regulatory strategy
  • Definition of the development milestones
  • Competitive regulatory intelligence
  • Planning of internal and external validation through board and agency meetings
  • Time and budget outline for the entire planning
  • Early versus late development planning
  • PRIME
  • Adaptive pathways
  • Assessment of CRO proposals
  • Immunogenicity risk assessment and preparation of the integrated summary of immunogenicity

Regulatory preparedness and planning

  • Trending, interpretation and impact discussion of regulatory requirements
  • Positioning and differentiation of products including HTA impact discussion
  • Regulatory Benefit/Risk determination throughout all development and approval phases
  • Scenario building – probability of success
 

CMC development planning

  • Milestone definition, planning of required packages for entire CMC dossier
  • Time and budget outline for the CMC planning
  • Manufacturing process: qualification, validation, critical quality and process attributes
  • Technology transfer: planning and execution
  • Selection of CMOs and review of CMO proposals, review of CMO reports
  • GMP audit
  • Product comparability strategy
  • Package definition for first-in-human studies versus pivotal studies requirements
  • Analytical package with validation package
  • Biopharmaceutical product quality control & characterisation
  • Bioassay definition
  • Validation of analytical & bioanalytical methods
  • In-house reference standard preparation
  • Stability packages
  • Adventitious agents’ safety packages
 

Non-clinical program planning

  • Definition of the program
  • Selection of CROs and review of CRO proposals
  • Issue resolution
  • Justification of in vitro based programs
  • Special programs for ATMPs
  • Review of reports
 

Clinical development program planning

  • Definition of the principle design of clinical studies
  • Definition of the rationale of use of the product and of the target population for development and approval
  • Statistical sample size determination
  • Selection of primary and secondary endpoints
  • Interpretation of your clinical data and their communication to regulatory agencies
 

Integration of a device

  • CE mark package
  • Combination products of device and biologicals
 

Review of regulatory submissions – is your development plan or data package sufficient and acceptable for regulators?

  • We can tell you what comments are to expect from the regulators
  • We review your development and regulatory plans
  • We provide gap analysis of data packages (CMC, pre-clinic, clinic) and offer potential solutions to close gaps
  • We offer Lessons Learned Sessions to analyse previous submissions