therainnova AG provides strategic advisory services to boards, CEOs, founders, investors, and biopharma leadership teams at value-critical inflection points across development, regulatory strategy, governance, and innovation.
We work with leadership teams making decisions that directly shape asset value, development timelines, and long-term positioning. Our approach is strategic, cross-functional, and international - drawing on deep experience across large pharma, biopharma entrepreneurship, and board-level advisory.
Based in Zürich, Switzerland. Operating across Europe and global biopharma markets.
Dr. Stephanie Krumholz — Founder & CEO
Dr. Stephanie Krumholz is the Founder & CEO of therainnova AG and a strategic biopharma advisor with more than 24 years of international experience spanning global biopharma, entrepreneurship, and advisory leadership.
Her career includes global regulatory leadership roles at Roche, where she contributed to major products including Tamiflu, NeoRecormon, Herceptin, and Actemra, a US expatriate assignment, two FDA Advisory Committee engagements, regulatory due diligence and transaction support within Roche's Pharma Partnering and M&A environment. Prior to Roche, she advised a venture capital company as a pharmacological consultant during her doctoral research. She later served as Head of Regulatory Affairs within a biotech environment before founding her first consulting company. The company was subsequently acquired by NDA Group, a Swedish life sciences consultancy, following which she served as General Manager and Board Member of NDA Switzerland and became part of the international management team. In these roles, she contributed to the growth and development of the business, established and expanded the Swiss affiliate, and supported clients across Europe, the United States, and other international markets. Following her exit from NDA, she founded therainnova AG in 2021.
Today, she advises senior executives, founders, investors, and biopharma leadership teams on value critical decisions at the intersection of regulatory strategy, governance, development, market access, and innovation. Her experience spans strategic advisory, business leadership, due diligence, international business development, and complex cross functional decision making across global biopharma environments. She completed the IMD Mastering Board Governance programme and is currently pursuing the IMD Board Readiness Diploma.
Dr. Krumholz holds a Dr. rer. medic. from Charité Berlin and a State Examination in Pharmacy from the University of Bonn. Based in Zürich, she advises clients across Europe, the United States, and selected global markets.
therainnova AG provides strategic advisory to boards, CEOs, founders, investors, and biopharma leadership teams at value-critical inflection points across development, regulatory strategy, governance, and innovation.
We work with leadership teams making decisions that directly shape asset value, development timelines, and long-term positioning. Our approach is strategic, cross-functional, and international — drawing on deep experience across large pharma, biopharma entrepreneurship, and board-level advisory.
Based in Zürich, Switzerland. Operating across Europe and global biopharma markets.
Dr. Stephanie Krumholz Founder & CEO
Dr. Stephanie Krumholz is the Founder & CEO of therainnova AG and a strategic biopharma advisor with 24+ years of international experience across Roche, biopharma leadership, and entrepreneurship.
Her career spans global regulatory leadership at Roche, including senior regulatory roles on blockbusters such as Tamiflu, NeoRecormon, Herceptin, and Actemra, a US expatriate assignment, and two FDA Advisory Committee engagements. During her time at Roche, her experience also included regulatory due diligence and strategic transaction support within Roche’s Pharma Partnering and M&A environment. Prior to Roche, she advised venture capital organisations as a pharmacological consultant during her doctoral research. She later served as Head of Regulatory Affairs within a biotech environment before founding and successfully exiting NDA Regulatory Service Switzerland GmbH and establishing therainnova AG in 2021.
She advises boards, CEOs, founders, investors, and biopharma leadership teams on value-critical decisions at the intersection of regulatory strategy, governance, development, and innovation. Her experience spans board-level advisory, governance oversight, international business scaling, due diligence, and complex cross-functional decision-making across global biopharma environments. She completed the IMD Mastering Board Governance programme and is currently pursuing the IMD Board Readiness diploma.
Dr. Krumholz holds a Dr. rer. medic. from Charité Berlin and a State Examination in Pharmacy from the University of Bonn. She is based in Zürich and operates internationally.
therainnova works with a trusted network of senior partners across CMC, (non-)clinical development, HTA, safety, and regulatory strategy.
Our Team
Who we are
Our team is passionate about creating smooth and efficient connections between regulatory processes and authorities.
General Manager
Stephanie Krumholz
Dr. Stephanie Krumholz is the founder and CEO of therainnova AG. With over 20 years of experience in the field of Regulatory Affairs, Dr. Krumholz is a seasoned expert in the industry. She holds a Dr. rer. medic thesis from the Department of Obstetrics and Gynaecology in Berlin, Germany and is a pharmacist by profession.
Dr. Krumholz specializes in leading and guiding biopharmaceutical companies in managing regulatory pathways in the EU and Switzerland, meeting and influencing health authority requirements, and increasing the value of a company's assets from a regulatory perspective. Her strong leadership, strategic thinking, and cross-functional teamwork skills have been honed through her experience working in both big pharma and small biotech companies, as well as consulting.
She has led Regulatory Affairs Projects from early development to filing marketing authorizations, new drug applications, and biologic drug applications in the EU, Switzerland, and US, across various therapeutic areas and products, including small molecules and biologics. Dr. Krumholz has also led health authority meetings in Europe, Switzerland, and globally, and has assisted companies in setting up their regulatory departments in Europe. Additionally, she has advised and submitted Scientific Advice Procedures, Acceleration Pathway submissions, Orphan Designations and Paediatric Plans in both Switzerland and Europe.
Dr. Krumholz successfully works in global partnerships and has supported projects such as Project Orbis and Access Consortium. She also has experience in issue management, handling due diligences, and worked in the M&A / venture capital field. Additionally, she spent 4 years living abroad in the US and has gained valuable experience in working with different cultures and customs, which have helped her to build strong relationships with people from all over the world.
Dr. Krumholz is dedicated to improving access to medicines for patients, using her skills and knowledge to make a real difference in people's lives.
