Service Portfolio
Strategy and organisational set-up to achieve and maintain Healthcare Compliance
Establishment of GxP audit & inspection readiness
GxP and regulatory crisis management
Provision of interim QPPV support
Organisational design
and process optimisation in clinical development, medical affairs and patient safety/pharmacovigilance
Focused on Neurodegenerative and Inflammatory Diseases/Immunology
customised expert advice and implementation support for
Establishment of development strategy including alignment with Key Opinion Leaders and Health Authorities
Set-up and coordination of registration enabling Preclinical Programs
Set-up and virtual management of Clinical Development Programs
Provision of Benefit/Risk Assessments
Leadership of Regulatory Strategy and management / oversight of Registration process
Oversee the development cycle (preclinical to product approval)
Lead Clinical Development, Medical Affairs and Safety
Spokesperson towards Health Authorities, Key Opinion Leaders, and Patient Advocacy
Interim management
Chief Medical Officer / Chief Development Officer
