We support pharmaceutical, biotech, cell & gene therapy, vaccine, CDMO/CMO, and GMP laboratory clients.
We operate globally, with offices in NC, WY, and Cancun, Mexico. We support both remote and on-site consulting.
Yes. We offer Person-in-Plant (PIP) support, mock audits, and real-time FDA inspection readiness services (see FDA Inspection References) for guidance:
FDA Inspection References: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references
It’s our proprietary approach to compliance: Diagnose → Design → Deliver. Each engagement is tailored to regulatory risk, operational urgency, and business goals.
Absolutely. We specialize in remediation strategy, CAPA planning, and implementation support for FDA enforcement actions. Learn more about the regulatory background in 21 CFR Part 210 and 211:
21 CFR Part 210 & 211: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C
It depends on your needs. Some projects are as short as 2 weeks, while full-scale remediations may run 6–18 months.
Book a 30-minute consultation through our booking page or email us at info@altabrisagroup.com.
Yes. Our initial strategy session is complimentary and intended for decision-makers evaluating GMP and FDA compliance needs.
We serve startups, mid-sized firms, and global organizations across the regulated life sciences sector.
