Who We Are
Led by Roland Buhler, a licensed pharmacist and senior regulatory executive with more than 20 years of experience, our consultancy specializes in guiding drug development programs through regulatory pathways.
Experience Highlights
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Vice President of Regulatory CMC at Syner-G BioPharma Group
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Director of Regulatory CMC at Cardinal Health, leading global submissions across US, EU, Asia, Latin America, and beyond
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Associate Director of Regulatory CMC at AbbVie, managing approvals across oncology, neuroscience, and immunology
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Progressed through leadership roles at Abbott Laboratories, leading compliance programs, acquisition integration, and global submissions
Therapeutic Area Expertise
​Oncology • Neuroscience • Immunology • Infectious Disease • Cardiovascular • Ophthalmology • Women’s and Men’s Health
Credentials & Memberships
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Regulatory Affairs Certification (RAC, US – Active)
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Licensed Pharmacist – State of Wisconsin
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BS, Pharmacy – University of Wisconsin–Madison
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Member, Regulatory Affairs Professional Society (RAPS) since 2005
Let’s streamline your regulatory path together.
Contact us to discuss how we can support your program — from strategy to submission,
from early development through commercialization.
262-206-4482