
Andemax Consulting Andemax Consulting supports virtual and emerging biopharmaceutical companies with phase-appropriate Quality and Compliance solutions, enabling teams to remain lean while meeting global GxP expectations and maintaining strong oversight of CDMO partners. We help clients design, implement, and sustain scalable Quality Management Systems, prepare confidently for regulatory inspections, qualify vendors, and establish practical documentation frameworks that evolve alongside program growth. Founded by Bianna Gal, Andemax Consulting brings over 25 years of experience in Quality and Compliance across the biotechnology and Cell & Gene Therapy sectors. Bianna’s expertise spans monoclonal antibodies and advanced therapies, with deep experience in batch record review, product release, cGMP audits, regulatory inspection readiness (FDA and EU), vendor qualification, quality agreements, SOP development, and documentation governance. Prior to founding Andemax Consulting, Bianna held senior Quality leadership roles at the Bill & Melinda Gates Medical Research Institute, IRX Therapeutics, and Pfizer, where she supported complex development programs and global regulatory initiatives. Service Provider

Andemax Consulting

Andemax Consulting supports virtual and emerging biopharmaceutical companies with phase-appropriate Quality and Compliance solutions, enabling teams to remain lean while meeting global GxP expectations and maintaining strong oversight of CDMO partners. We help clients design, implement, and sustain scalable Quality Management Systems, prepare confidently for regulatory inspections, qualify vendors, and establish practical documentation frameworks that evolve alongside program growth. Founded by Bianna Gal, Andemax Consulting brings over 25 years of experience in Quality and Compliance across the biotechnology and Cell & Gene Therapy sectors. Bianna’s expertise spans monoclonal antibodies and advanced therapies, with deep experience in batch record review, product release, cGMP audits, regulatory inspection readiness (FDA and EU), vendor qualification, quality agreements, SOP development, and documentation governance. Prior to founding Andemax Consulting, Bianna held senior Quality leadership roles at the Bill & Melinda Gates Medical Research Institute, IRX Therapeutics, and Pfizer, where she supported complex development programs and global regulatory initiatives.

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