Business Development / Licensing
- Search for and identification of potential licensed products or license partners (Scouting)
- Contact and exploration, presentation of the license offer
- Contract negotiations
- Due diligence activities
- Alliance Management
Regulatory Affairs / Marketing Authorization
- Development of registration strategies for new drugs and their implementation
- Analysis of registration dossiers and individual documents
- Advice and implementation of scientific advice procedures with regulatory authorities
- Advice and support with marketing authorization submissions, queries / objections from the authorities until approval is granted
- Maintenance: marketing authorization renewals, extensions, variations, periodic safety update reports / PSURs, safety procedures and safety communication
- Analog procedures in the field of material or digital medical devices
Medical Affairs / Medical Scientific Information
- Medical scientific positioning and profiling of pharmaceuticals in the therapeutic areas of cardiovascular medicine, psychiatry / neurology, bone metabolism, oncology and ophthalmology
- Advice on the design, implementation, analysis and publication of scientific studies after authorization: Phase IV studies and non-interventional studies (NIS)
- Assumption of the responsible function of Information Officer according to §74a AMG
Market Access
- Advice and support in the area of benefit assessment of medicinal products (AMNOG procedure) and pricing / reimbursement by the health insurance companies for new drugs
- Gap analysis of the clinical trial situation for the benefit assessment vs. appropriate comparator therapy (ZVT)
- Support in scientific consultation procedures and hearings at the GBA
- Support with dossier preparation
Quality Assurance
- Identification and implementation of relevant GMP and GDP principles for pharmaceutical distribution companies
- Development and maintenance of a functionally adapted quality assurance (QA) system with implementation in written procedural instructions (SOPs)
- Support in carrying out self-inspections and audits, reporting and following up on the necessary actions
- Advice and support during inspections by authorities (Company Escort)
- Assumption of the responsible function of Wholesale Representative according to §52a AMG
