Overview of services:
- Regulatory strategic advice «beyond standard» to pharmaceutical executives and investors based on 30+ years of international regulatory experience
- Advice and review of drug development programs including LCM, assessment of regulatory dossiers, CMC and clinical key documents and regulatory application of AI
- Regulatory advice and support in the transformation of small and mid-size pharmaceutical companies to global players
- Establishment and optimization of RA departments and mentoring of talents
- Negotiation of scenarios including labels with health agencies including FDA and EMA
