Regulatory Affairs
Support in preparation and audit of submission documents as well as meetings with National Competent Authorities and Notified Bodies.
Quality Assurance
Assistance in the fields of Pharma (e.g. cGMP, GDP, QMS and Supplier qualification) as well as MedTech (e.g. ISO 13485, ISO 14971, Technical File)
Coaching
Coaching startups in the fields of Life Science, specifically Pharma, MedTech and Biotech. Support in writing, refining business plans and approaching investors.