Overview
Located in Athens, Greece
- 3,000 sqm of R&D facilities
- Site operational since: 2014
- Recently upgraded with HPAPI capabilities
- Expertise in Value Added Medicines
- Agile, fast and flexible operating model
- 65+ Specialized professionals
- Experience with over 150 molecules
- 25+ Years of successful developments
Technologies / services
Formulation development
- API characterization
- Preformulation
- Formulation development
- Analytical method development
- Process development
- Technology transfer
- IP Search
Analytical services
- Method development & validation
- Chemical compatibility
- Forced degradation
- Dissolution (USP I, II and III)
- Chemical analysis of APIs
- Finished product controls
- ICH stability, photostability and in-use stability
Scientific and Clinical Development
- Clinical Strategy
- Study design & Sample size calculation
- BCS Biowaivers
- Dissolution data analysis
- IVIVC
- Clinical Trial Project Management
- Nonclinical and Clinical overviews
- Scientific advice meetings
Regulatory services
- Regulatory & registration strategy
- Scientific report writing
- Compilation and publishing of data in eCTD format
- Liaising with regulatory authorities
- Registration services and support
- Risk assessment reports
Supply Chain & Planning
- API and CMO qualification
- Coordination of registration batches
- Commercial production planning
- Finished product supply
- Raw material sourcing
- Inventory management and optimization
- Selection of sustainable suppliers
