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