Active Partners in Your
Quality and Regulatory Success
Our expert partners actively review and certify our documents, conduct mock inspections, lead client workshops, and provide direct support that extends far beyond our dashboard capabilities. Their hands-on involvement ensures you receive expert validation and personalized guidance at every step.
Austin Caudle
Pharmaceutical business development leader with 20+ years of experience across Fortune 500 companies including IQVIA, Thermo Fisher, and Charles River. Fierce advocate for quality, compliance, and technology-enabled process improvement in pharmaceutical manufacturing.
Archana Gangakhedkar
Life sciences marketing and commercialization leader with 15+ patents and regulatory expertise. Brings scientific rigor and go-to-market strategy from Dr. Reddy's, Affymax, XenoPort, Bachem, and Thermo Fisher Scientific. Expert in cGMP, eCTD CMC submissions, and quality control. Helps GKS accelerate impact and unlock new opportunities through clear, strategic communication.
Dr. Cheryl Roche Alexander
Advises on clinical trial development, project strategy, and project/program management. Has additional background and experience across medical, healthcare, market access, and commercial functions in the biopharmaceutical industry.
Daniel Baretto
Leads strategic quality and regulatory programs for life sciences clients globally. Offers deep expertise in pharmaceutical compliance and risk-based inspection preparedness, drawing from decades of experience in FDA-regulated environments.
David Mishler
David specializes in Quality & IT business consulting, empowering small to medium-sized life sciences organizations to achieve compliance and operational efficiency.
Dr. Helene D. Clayton-Jeter
With 30+ years of experience, Dr. Helene D. Clayton-Jeter helps life science companies drive innovation, safeguard patients, and navigate complex regulatory pathways.
Kasia Grzelecka MBA
Advises on life sciences trends, product strategy, and market expansion. Supports executive leadership in positioning the platform as a category-defining solution for regulatory readiness. Brings 25+ years of experience in biopharma, helping secure key Fortune 500 clients and fueling a growth in inbound engagement.
Dr. Ligia Zubik, Ph.D., ASQ‑CQA
Quality assurance leader with 20+ years in GxP auditing and compliance. ASQ‑CQA-certified and recognized GMP lead auditor driving quality systems and lab method validation.
Martin Orcoyen
Advises on GMP compliance, project strategy, and talent development across the pharmaceutical and biotech sectors. Brings a unique blend of scientific training, business acumen, and leadership in international industry networks.
Taggart McGurrin, JD, MBA, CPA
Taggart "Tagg" McGurrin, JD, MBA, CPA, is a dynamic biotech finance executive with a decade of leadership experience driving capital formation, strategic growth, and operational scale.
Vyjayanthi (Vyjoo) Krishnan
Biotech executive with 25+ years of global experience leading CMC strategy, GxP operations, and product development across peptides, biologics, and gene therapies. Supports GKS's mission to simplify compliance and accelerate readiness for life sciences companies.
Whitney Smith
Whitney is Co-founder and Principal at Flourish Consulting LLC, providing consulting services, strategic advising, and fractional sales executive expertise to the software and pharma industry.
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