10 regulatory affairs consultants

Experience: President, EVP of Regulatory and Clinical Affairs · R & C Consulting Group LLC

President, EVP of Regulatory and Clinical Affairs at R & C Consulting Group LLC since 2006; her profile describes strategic and operational experience in medical device, biotechnology and pharmaceutical regulatory affairs, clinical trials, HEOR and quality assurance. She was also Sr. Vice President of World Wide Regulatory Affairs, Clinical Research, and Quality at MicroVention, Inc, Terumo (2015–2021).

Experience: Principal Consultant and Founder · Gaia Regulatory Sciences, LLC

Principal Consultant and Founder of Gaia Regulatory Sciences, LLC since 2016; her profile says she provides strategic due diligence and product development and approval strategies through the consultancy, with a focus on investigational therapies. She was previously Head of Regulatory, Rare Diseases at NovusLife, LLC (2015–2016) and Director, Regulatory Science, Drugs Biologics at VCLS (Voisin Consulting Life Sciences) (2014–2015).

Experience: President · Regulatory Pharma Consultants, LLC

President of Regulatory Pharma Consultants, LLC since 2021, a title the listing also shows there for 2000–2005, and former Principal Consultant at NDA Group - an SSI Strategy Company (2020–2021). Her profile describes regulatory affairs expertise for global pharmaceutical companies, including health agency communications with FDA and EMA. She was also Vice President Regulatory Affairs at Botanix Pharmaceuticals (2018–2020).

Experience: Independent Regulatory Consultant · KM Consulting

Independent Regulatory Consultant at KM Consulting since 2020; her profile describes leading health authority submissions and interactions as a consultant for preclinical and clinical stage drug, biologic and medical device companies. She was previously Regulatory Strategy Consultant at Halloran Consulting Group, Inc., a PLG Company (2018–2020), Regulatory Consultant at ProEd Regulatory (2017–2018) and Regulatory Project Manager at FDA (2016–2017).

Experience: Regulatory Affairs Consultant · The Lyon Method: Regulatory Solutions LLC

Regulatory Affairs Consultant at The Lyon Method: Regulatory Solutions LLC since 2025; her profile describes her as founder and principal consultant of the firm and, in its headline, as a global regulatory affairs leader and FDA and EU MDR strategist. She was previously Regulatory Professional at Organogenesis (2019–2025) and has been Adjunct Professor at Northeastern University since 2018.

Experience: Director and Owner · Thyregod Consulting ApS

Director and Owner of Thyregod Consulting ApS since 2022; her profile describes an independent senior regulatory affairs and quality assurance consultant with a history in the pharmaceuticals industry, skilled in medical devices, GxP and cosmetics. She was previously Head of Regulatory Affairs & Quality Assurance, Denmark at PharmaRelations (2020–2022) and Senior Specialist (Consultant) at A-consult A/S (part of AlfaNordic Group) (2019–2020).

Experience: Senior Regulatory Affairs Consultant · M Jonsson Regulatory Consulting AB

Senior Regulatory Affairs Consultant at M Jonsson Regulatory Consulting AB since 2022 and Consulting Manager and Senior Consultant at NDA Group - an SSI Strategy Company since 2022. She was previously Director Regulatory Affairs and deputy QPPV at AGB-Pharma AB (2020–2022), Director Regulatory and Safety at LINK Medical (2018–2020) and Director Regulatory Affairs and deputy QPPV at Galenica AB (2013–2018).

Experience: Founder and Principal, Global Reguatory Affairs · MT Pharma Consulting LLC

Founder and Principal, Global Reguatory Affairs at MT Pharma Consulting LLC since 2014; his profile describes a regulatory strategy consultant in global regulatory affairs who translates scientific, regulatory and business considerations into strategies that advance programs from development through approval. He was also Executive Director, Regulatory Affairs at Veru Inc. (2022–2023) and Manager at PwC (2011–2014).

Experience: Principal Consultant · Nicola Selley Regulatory Consulting

Principal Consultant at Nicola Selley Regulatory Consulting since 2014 and Engagement Partner - Regulatory Affairs & Women's Health at Bruder Consulting and Venture Group since 2018; her profile headline describes her as a regulatory affairs consultant for medical devices. She was previously Executive Vice-President, Regulatory Affairs at Suneva Medical (2013–2014) and Vice-President WW, Regulatory Affairs (Multiple J&J Business Units) at Johnson & Johnson (2009–2012).

Experience: Principal Owner · Stonecroft Consulting, LLC

Principal Owner of Stonecroft Consulting, LLC since 2016; her profile says she provides regulatory consultation and assistance to the pharmaceutical, medical device, biomedical, food, cosmetic and dietary supplement industries. Her listed FDA roles include Senior Case Review Expert (2008–2015), Compliance Officer (2001–2008) and Supervisory Consumer Safety Officer (2000–2001).