RRD MODEL AND SERVICES

CMC and Analytical Support

RRD Partners benefit from a strategic regulatory driven-approach to early development with a fully engaged, seasoned team on day 1. CMC domains include:

  • Bench to pilot scale tech transfer
  • Pilot engineering activities
  • Dose justification for GLP toxicology studies
  • Analytical development programs
  • GMP manufacture of clinical doses
  • Stability studies
  • Process improvement and change

Value

Prospective design = efficient product and process development

Identify and manage qualified vendors

Determine phase-appropriate standards

Manage risks to avoid gaps in documentation

The right CMC plan grows asset value

CMC Services

Oversee Outsourced Manufacturing and Testing

  • Design GMP Process
  • Analytical and control strategies
  • Conduct Process and analytical gap analyses

Direct ICH Stability Study Design and Oversight

  • In-use stability/compatability studies
  • Manage reference standard strategy and logistics

GMP QMS System Support – Write, Review, Revise SOPs, Master Batch Records and Stability Programs

  • Review executed testing records
  • Review executed manufacturing records

Author and Review Regulatory Submissions

  • Author Module 3 submissions
  • Review Module 3 submissions

Scientific Support

Strategic and Scientific Support for New Technology Evaluation and Selection

  • Diligence for asset evaluation and licensing
  • Authoring/review target product profile

Process Development and Scale-Up Support

  • Raw material selection and sourcing
  • Biological starting material
  • Viral and TSE safety strategies
  • Science-based risk management per ICH Q9
  • Science-based development strategy per ICH Q11

Regulatory Strategy and Submission

  • Regulatory submission preparation and filing
  • Preparation for and participation in regulatory meetings
  • Product labeling development
  • Preparation of Advisory Committee presentation
  • iPSP support

Technical Operations Offerings

Oversight/Management of Outsourced Activities

  • Vendor search, RFP development, bidding and selection with contracting support
  • Site inspections/qualification audits
  • Risk management plans
  • Comprehensive process/assay development and validation support
  • Management of biorepository storage
  • Support for deviation resolution at CDMOs/vendors
  • Tech transfer management to new manufacturing and testing facilties
  • Support for complex animal-based or cell-based assay
  • Support for biosample collection & management

Oversight/Management of Outsourced Activities

  • Vendor search, RFP development, bidding and selection with contracting support
  • Site inspections/qualification audits
  • Risk management plans
  • Comprehensive process/assay development and validation support
  • Management of biorepository storage
  • Support for deviation resolution at CDMOs/vendors
  • Tech transfer management to new manufacturing and testing facilties
  • Support for complex animal-based or cell-based assay
  • Support for biosample collection & management