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.
