Cell Therapy and Biologics

Regulatory and quality processes towards both EU and US clinical trial readiness, Marketing Application Authorization (EMA), Biological License Application (FDA) and GDP activities

Services in the area of quality and regulatory affairs in both EU and US.

Regulatory Strategy and Due Diligence
  • Fast track opportunities such as PRIME/ RMAT/ Innovation task force/ COVID
  • Strategic regulatory road map from product development to product approval
  • Strategic road map combining regulatory and commercial aspects to facilitate new funding
  • Gap assessments RA/QA/QC
QA/QC/GMP Development
  • Set-up or improvement of GMP or GDP compliant quality management systems
  • Quality by Design
  • Process Risk Management
  • Validation Processes, Methods
  • Comparability strategy and technology transfer
  • Internal audits
  • Supplier audits and qualification including QA Agreements, including Tissue Banks
  • (Interim) Quality Management or quality support.
  • Support in Competent Authority inspections including preparation, hosting and follow-up.
Regulatory writing and project management
  • CTA – Clinical Trial Applications
  • IMPD
  • (pre) IND
  • Scientific Advice (EMA / national)
  • MAA / BLA
  • ODD, Orphan Application
  • CMC
  • Interactions with FDA and EU Regulatory Authorities
  • Responsible Person for Wholesale Dealers license services
  • Wholesale Dealers license applications
  • GDP compliant QMS systems
  • QA Agreements
  • GDP audits
Specific Projects

Multiple regulatory strategies, approvals and support for a diverse spectrum of cell therapy and biologics solutions as well as QA support

  • Advanced Therapy Medicinal Products such as:
    • Cell therapy (various cancer immunotherapies, monoclonal antibody therapies, tissue engineering solutions, vaccine’s)
    • Gene therapy (eg COVID-19)
    • Tissue engineering (Bone, skin, cartilage, cardiovascular tissue)
  • Haemostatic tissue sealants / dressings and other combination products