Key areas of expertise:
- Regulatory affairs (IVDR, MDR) + Quality management
- Performance evaluation and technical documentation
- Medical laboratory accreditation
- Laboratory developed (in-house) tests (LDTs)
- Risk management and usability engineering
- Companion diagnostics + complementary diagnostics
- Strong background in clinical development and medical indications
Other
- Start-up coaching: Biotech and medtech startups
- Biomarker solutions for pharmaceutical and vaccine development
News & Activities
- March 2018
First version ME PharmaConsult website going online - March 2021
Foundation of ME PharmaConsult GmbH, 8280 Kreuzlingen, Switzerland - February 2022
Prof. Martin Elmlinger elected Vice Chairman of the multi-national cluster BioLAGO e.V. - April 2022
renewed website of ME PharmaConsult GmbH going online - 4-5th May 2022
Attending Deutsche Biotechnologietage, Hamburg. Meet Martin Elmlinger at the BioLAGO booth.
Teilnahme an gemeinsamer Dialogveranstaltung von PEI und BfArM: IVDR: "Neue Regelungen für IVD und therapiebegleitende Diagnostika (CDx)"
In-vitro diagnostics: From product development to registration
"We serve manufacturers and clinical laboratories"
Please contact us to explain your needs and ask for a quote:
SERVICES PROVIDED
Regulatory affairs and quality management (EU, US, Switzerland)
- IVDD/IVDR, MDCG-2020-16, 510K
- Technical file, development file
- Quality management system (ISO 13485)
- Risk Management (ISO 14791, ISO 22367:2020-09)
- Usability testing (ISO 62366-1)
- IVD as a software (IEC 62304, MEDDEV 2.1/6)
- LDT/in-house tests under IVDR and ISO 15189 and RiLiBÄK
Performance evaluation and the respective documents (IVDR Annex I+II, Art. 56)
- Performance evaluation plan (PEP) and report (PER)
- State-of-the-art analysis
- Scientific validity report
- Verification of analytical performance (also using CLSI norms)
- Clinical performance strategy, also for challenging IVD products
- Critical appraisal of clinical performance (literature-based)
- Clinical study planning and performing (ISO 20916:2019)
- Plan and perform usability studies (professional and lay users)
Delivery of qualified biomarkers for pharma projects
- Identify suitable biomarker candidates based on science
- Companion diagnostics and complementary diagnostics (co-development with pharmaceuticals)
- Regulatory and technical utility for clinical studies and implemenation
Startup Coaching
"We love to turn great ideas into a product"
- Develop a regulatory strategy
- Find grants and investors
- Assess commercial potential
- Find a shortcut to satisfying revenues
About
Dr. Martin Elmlinger (CEO). Global expert of in vitro-diagnostics and clinical biomarkers.
After his PhD in biology (1993), he became a science group leader and clinical laboratory head at the University Childrens Hospital of Tuebingen (D), where he was awarded the Juergen Bierich research prize (1998) and -after habilitation in medicine- an extraordinary professorship at the University of Tuebingen. As the laboratory head of the University Children´s Hospital, he ISO 15189-accredited the laboratory and developed a number of in-vitro diagnostic (IVDs) assays for scientific projects and commericial use. In 2005 he switched to pharma industry (ALTANA, Nycomed, Takeda), where he was responsible for clinical biomarker development to foster the development of drugs and in 2013 he became the global Head of Serology for vaccine development at Takeda International. In 2018, he re-entered the world of IVDs and medical devices and qualified in regulatory affairs, quality systems and risk management, as a consultant. He is now enthusiastic about helping SMEs and big diagnostics companies with the performance evaluation to bring even demanding IVD products to market. In addition, he also has fun helping medical medical startups as a business coach at the Steinbeis Stiftung and Startup Center University of Tübingen.
Top milestones:
- 02/2021 ME PharmaConsult GmbH founded
- 2018 Senior Consultant Regulatory Affairs and Biomarkers
- 2017 Senior Director, Global Serology & Assay Strategy, Takeda Vaccines, Zürich-CH
- 2012 Director, Pipeline Sourcing & Portfolio Management, Nycomed, Zürich-CH
- 2010 Director, Biomarker Development, ALTANA and Nycomed Pharma, Konstanz-D
- 1994-2005 Associate Professor, University Childrens´ Hospital, Tuebingen-D
Memberships
- Deutsche Gesellschaft für Klinische Chemie und Laboratoriumsmedizin (DGKL)
- BioLago e.V. Bodensee-Region (Vice chair)
- Steinbeis Stiftung - (startup coach of Transferzentrum)
- Startup Center, University of Tübingen
- FAMH Switzerland (pending)
Network
Institutions & Clusters
https://www.wiwoco.ch/
University of Konstanz, Department of Biology, AG Prof. E. Deuerling
Info zur Firma oder zur Zusammenarbeit?
Contact
Martin Elmlinger
me.pharmaconsult@gmail.com