Welcome to Lindland Roest ApS – a professional pharmaceutical consulting business offering services to biotech and pharmaceutical companies. With a strong scientific background founded in Regulatory Affairs, Lindland Roest provides hands-on expertise & strategic advice within three main areas:

  • Efficient project management in pharmaceutical and biotech development
  • Writing and reviewing the Quality section of the Investigational Medical Product Dossier (IMPD – drug substance & drug product)
  • CMC coordination with Contract Manufacturing Organisations
  • Scientific Advice Application, Preparation and Management
  • Regulatory and Development Strategy
  • CTA Key Documentation Preparation and Regulatory Review
  • CTA Application and Maintenance