Experienced Clinical Trial Regulatory Consultant

Clinical Trial Regulatory Strategist with over 9 years of experience in pharma, skilled in formulating submission strategies and adeptly leading projects and teams through the regulatory landscape. Certified EMA CTIS Sponsor Master Trainer.

• CPP
• CTIS
• EU CTR
• Gute Klinische Praxis
• Klinische Forschung
• regulatory strategy
• Spezialist Regulatory Affairs
• Training - Coaching-Kompetenzen

Providing regulatory consulting services, such as:
 EU CTR and CTIS implementation and interplay with other regulations (e.g. Switzerland new Clinical Trials Ordinance)
 Core documents regulatory review (Protocol, IB, ICF etc.)
 Clinical trials submission strategy to RA and IRB/IEC (CTA)
 EU CTR and CTIS training
 Optimizing EMA CPP submissions (WHO Certification Scheme).