leap:up GmbH
About us
leap:up GmbH – The Life Science Enabler
leap:up GmbH (formerly biosaxony Management GmbH) empowers founders, startups, and SMEs in the life sciences to take significant steps towards innovation, market entry, commercialization, and growth.
"leap:up" stands for bold leaps into the future of life sciences. As a life science enabler, we create optimal conditions for the realization of groundbreaking ideas.
Our portfolio includes acceleration and development services for life science projects, regulatory support, training programs, and events through our in-house academy, as well as the provision of state-of-the-art co-working labs in Leipzig. We are actively expanding our international presence and service, including investor relations and funding opportunities.
Our focus areas include diagnostics, cell and gene therapy, radiopharmacy, smart medical devices, robotics and AI, digital health, and phage therapy.
Local work is strengthened by leap:up’s two offices in Leipzig and Dresden.
Address
Deutscher Platz 5c
04103 Leipzig
Germany
E-mail: andre.hofmann@leap-up.com
Phone: +49 176 17965501
Internet: www.leap-up.com/
Contact person:
Dr. Maike Rochon
Head of Strategy & Innovation Management
E-mail: maike.rochon@leap-up.com
Phone: +49 162 6051800
Products & Services
The MEDICAL FORGE LEIPZIG supports startups and innovative companies to bring their medical products faster to the German healthcare market. The customized 12 months program focuses on the specific needs of young medical technology companies.
Our extensive network including hospitals, health insurances and experienced industry partners will provide you with invaluable insights and project opportunities.
We offer you an in-kind service bundle with an overall value of 185,000 Euro including coworking laboratories, offices and electronic workshops, as well as personal consulting, mentoring, and much more. You have to provide 21,000 Euro of your own capital. However, you will receive a 25,000 Euro team budget during the program.
Forge your way to the healthcare market with us!
Consulting
Site Marketing – national, international
Market Research & Market Access
Project Acquisition & Financing
Strategy & Finance, Investor Relations
Networking & Cooperation
Networking Events
Business Matchmaking
Contact Initiation
Establishment of Strategic Partnerships
Representing your Interests at Partnering Conferences
Regulatory Affairs Services for Life Sciences
Establishment of a quality management system according to ISO 13485:2021
Document Review according to MDR 745/2017 or IVDR 746/2017
Provision of external Person Responsible for Regulatory Compliance (PPRC) / Quality Management
Representative (QMR)
Provision of an authorised representative (EC-Rep) mandatory for manufacturers of medical devices /in-vitro diagnostic devices based outside the EU, with tasks such as:
Review of the issued EU Declaration of Conformity and the corresponding conformity assessment procedure
Review of the up-to-dateness of the technical documentation
Contact person for national authorities Review and advice on specific topics such as:
Risk Management | Clinical Evaluation |Usability
Software Lifecycle | Post Market Surveillance