Initial marketing authorization application support
Case studies:
Regulatory Affairs
- Variation management
- Market entry management
Pharmacovigilance
- TOP10 pharma local represenation
- Small-biotech company consultancy and PV representation
- Vaccine (including COVID-19) PV services
- Regional PV support
- additional Risk Minimisation Measures:
- Reached over 20.000 healthcare professionals
- DHPC distribution (20% of the overall delivered DHPCs in Hungary)
- Education material development
- Artwork management, printing support
Product Development
- Early-phase quality and pre-clinical consultancy
- IMP manufacturing GMP certification
Quality Management
- Manufacturing site QMS development
- Qualification/Validation support
- Site master file compilation
Medical Affairs
- GAP analysis
- RA
- MA representative
- Procedure setup
Medical Device
- QMS consultancy in line with ISO13485 and MDR/IVDR relations
- Technical documentation writing in line with MDR requirements
- Support of implant registration under MDR