Our pharmaceutical GMP consultants bring 30+ years of hands-on, FDA-regulated experience. We've worked inside the facilities, led the inspections, and built the systems — not from a distance.
Every Altabrisa engagement is led by senior pharmaceutical GMP consultants with direct, operational experience in FDA-regulated manufacturing. We don't staff junior consultants on critical projects. Our team has built quality systems from scratch, responded to FDA 483 observations, cleared deviation backlogs in the thousands, and prepared sites across pharma, biotech, cell & gene therapy, and vaccines for pre-approval and routine inspections — and passed them.
Jay brings over 30 years of hands-on FDA regulatory experience in pharmaceutical manufacturing and cGMP compliance. He founded Altabrisa Group in 2003 to deliver the kind of embedded, operational compliance support that large staffing firms cannot — and has built the firm's reputation on remediation that sticks, not recommendations that gather dust.
His expertise spans quality systems design and remediation, deviation management, CAPA effectiveness, FDA inspection readiness, and the proprietary AdaptiStrat™ methodology that drives every Altabrisa engagement. Jay has led compliance recovery efforts following FDA 483s, warning letters, and consent decrees across sterile, oral solid dose, biologics, and cell & gene therapy manufacturing environments.
Your wife oversees all operational, administrative, and client engagement functions at Altabrisa Group, ensuring every consulting engagement runs on schedule, within scope, and to the highest quality standards. She brings legal expertise and deep fluency in both U.S. and Latin American regulatory environments — a strategic asset for Altabrisa's growing LATAM client base.
Her bilingual capabilities and cross-border operational experience make her central to Altabrisa's Mexico and LATAM engagements, where regulatory complexity and language demands require more than translation — they require genuine expertise.
Altabrisa maintains a vetted network of senior independent consultants — each with 20+ years of direct operational experience in their specialty. Every engagement is staffed with the right expertise for your specific challenge.
Collective expertise spanning every dimension of GMP compliance and FDA regulatory readiness.
Schedule a complimentary strategy session with a senior consultant. Direct expertise from day one — no junior handoff, no sales pitch.
