Area of expertise
Market Access, RWE & Reimbursement
Approval is not commercial success. Reimbursement and price are decided in separate procedures with their own evidence logic, from German AMNOG benefit assessment through HTA dossiers to the EU-wide Joint Clinical Assessment (JCA). We combine value strategy, real-world evidence and pricing into robust market access, aligned with the appropriate comparator and payer requirements.
- Biotech
- IVD
- MedTech
- Pharma
All topics
8 topics in Market Access, RWE & Reimbursement
HEOR & Modeling →
Health economic modeling for pharma, biotech, medtech and IVD: cost-effectiveness (CEA), cost-utility (CUA) and budget impact models, including deterministic and probabilistic sensitivity analyses. Built to the reference cases of NICE, IQWiG and ICER and aligned with the Joint Clinical Assessment under the EU HTA Regulation (EU) 2021/2282: transparent and audit-ready instead of a black box.
HTA Dossier →
Preparation of complete HTA dossiers for the early benefit assessment under AMNOG (G-BA / IQWiG), the NICE Single Technology Appraisal, the HAS assessment and SGB V §137h: from the choice of comparator through endpoint structure and mock reviews to support during the written commenting phase and the oral hearing. For pharma, biotech, MedTech and IVD.
Market Access Strategy →
Market access strategy for pharma, biotech, MedTech and IVD: early planning of reimbursement requirements, definition of defensible price corridors, stakeholder positioning toward G-BA, IQWiG and payers, plus alignment with the AMNOG benefit assessment under § 35a SGB V and the EU-wide Joint Clinical Assessment under EU 2021/2282, beginning in early clinical development rather than at market launch.
Medical Science Liaison →
MSL services for pharma and biotech: interim MSL teams, KOL mapping and engagement, advisory board management, plus scientific communication and support for investigator-initiated trials as a non-promotional Medical Affairs function, cleanly separated from commercial activities.
Pricing & Reimbursement →
Pricing and reimbursement advisory for medicinal products and medical devices: launch price setting, the AMNOG procedure under § 35a and § 130b SGB V, management of external reference pricing, performance- and volume-based reimbursement agreements, and the reimbursement pathways for MedTech and IVD via the NUB application and § 137h SGB V.
Real-World Evidence →
Real-world evidence consulting for pharma, biotech, MedTech and IVD: design of methodologically robust registry, observational and secondary-data studies whose evidence meets the requirements of HTA bodies, regulatory authorities and payers. From the directed research question through the data strategy to PMCF and PMPF integration.
Tender & Negotiation →
Hands-on tender and negotiation support for pharma, biotech, MedTech and IVD: assessment of tender documents under GWB public procurement law, bid strategy for rebate contracts under SGB V § 130a Abs. 8 and aids supply contracts under SGB V § 127, win/loss analyses, and senior consultants supporting you directly at the negotiating table.
Value Dossier →
Global value dossiers in line with the AMCP Format for Formulary Submissions: robust evidence synthesis, a value narrative written from the payer and reviewer perspective, and a regionally adaptable line of argument toward payers and HTA bodies for pharma, biotech and medtech.
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Product Development & Regulatory Strategy
From classification and regulatory strategy through to development and study planning.
Regulatory Affairs
Approval and conformity under MDR, IVDR and pharmaceutical law, from the technical documentation to the notified body.
Quality Management & Compliance
QM systems, audits, computer system validation and data integrity under ISO 13485, GMP and 21 CFR Part 11.
Supply Chain & Technical Operations
Supply chain, manufacturing, shortage management and technical operations optimization.
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