Drug Nanotechnology Services

Thanks to our strong network of expert companies, leon-nanodrugs supplies a fully-inclusive service - from initial product concept to market launch. Our drug nanotechnology services include:

Conception and consulting

Project definition, definition of milestones, project task manual including time and cost plan, reimbursement strategies

Regulatory clearance

Advice meeting FDA, EMA, BfArM

Feasibility

ICH stability assay, ICH impurity method, solubility studies, technical proof-of-concept, API-specific nanoparticle database

Patent

Detailed patent research, patent formulation, patent submission

Biological profiling

Caco-2-studies, in vivo pharmacology studies in rats (non-GLP conditions), in vivo pharmacokinetics in dogs or pigs (GLP conditions), GLP-bioanalytics

Technical development

Optimisation, end formulation studies, scale-up, GMP Manufacturing of clinical trial material

Clinical trials

Based on advice meeting, Phase I, II, III

Documentation

Project Masterfile

Technology transfer

Construction of MJR production plant and technology transfer, scale-up, process validation and ICH stability (three batches)

Project management

Complete project management regarding communication, project execution, controlling