Supporting biotech and emerging biopharma organizations from early development through commercialization.
Helping teams build sustainable Quality Management Systems, navigate global GxP expectations, and partner with the right manufacturing and testing organizations.
A boutique Quality Assurance and Compliance consulting firm supporting Biotech, Pharma, and Cell & Gene Therapy companies with practical, phase-appropriate solutions.
Andemax Consulting supports virtual and emerging biopharma organizations with phase-appropriate Quality and Compliance solutions—helping teams remain lean while meeting global GxP expectations and ensuring strong CDMO oversight.
We help clients establish and maintain sustainable Quality Management Systems, prepare for inspections, qualify vendors, and implement practical documentation frameworks that scale with program needs.
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Bianna Gal is the Founder and Principal of Andemax Consulting and brings over 25 years of experience in Quality and Compliance within the biotechnology and Cell & Gene Therapy sectors.
Her experience spans monoclonal antibodies and advanced therapies, including batch record review, product release, cGMP audits, regulatory inspection readiness (FDA and EU), vendor qualification, quality agreements, SOP frameworks, and documentation governance.
Prior to founding Andemax Consulting, Bianna held senior Quality roles at the Bill & Melinda Gates Medical Research Institute, IRX Therapeutics, and Pfizer.
Practical, phase-appropriate support across Quality Systems, compliance execution, and partner oversight.
To discuss your Quality and Compliance needs, please reach out using the form below.
Quality Assurance & Compliance Consulting Services
