Services Provided
Organisational design and process optimisation in clinical development, medical affairs and patient safety/pharmacovigilance
Strategy and organisational set-up for Medical Affairs to achieve and maintain Healthcare Compliance
Establishment of GxP audit & inspection readiness
GxP and Regulatory Crisis Management
Provision of interim QPPV support and medical benefit-risk assessments
Focused on 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
Leadership of Regulatory Strategy and management / oversight of Registration process
Interim management as Chief Medical Officer / Chief Development Officer