Strategic Regulatory Affairs Consulting Services

Geoff brings 20+ years of expertise and a demonstrated record of regulatory and business accomplishments covering the United States, Europe, Asia Pacific (with in depth experience in Japan, China, and Korea), and Middle East having lived and worked in many countries championing regulatory affairs.

Oxana has more than 15 years of experience in the healthcare industry including the last 10+ years in regulatory affairs. She specializes in global regulatory strategy and drug development for rare diseases, pediatrics, and biosimilars, with a focus on Chemistry, Manufacturing and Control (CMC). She has hands on experience with regulatory mee...

Over 20 years in the industry; from a lab-based non-clinical pathology start, to quality management, safety management and regulatory affairs. Experience across ATMPs to consumer healthcare for small biotechs through to blue chip pharma, in senior management, leadership and consulting positions. Until recently working at the forefront of micr...