Welcome to our FAQ section Life Science Quality, cGMP, and FDA Compliance Consulting.
Below you’ll find answers to the most common queries about our FDA compliance and GMP consulting services. Whether you’re exploring how we can support your organization or looking for details on regulations, this guide has you covered. If you don’t see your question here, contact us directly or book a consultation.
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.
“Altabrisa built a clear, achievable plan and worked with our team until every issue was resolved. We passed our first bi-annual inspection without a single citation.”
“We were drowning in over 600 open deviations. Within months, they helped us streamline investigations, retrain our staff, and clear the backlog while improving quality. Incredible turnaround.”
“We knew our QMS wouldn’t hold up under FDA scrutiny. Altabrisa assessed everything and guided us through a complete remediation We’re now fully aligned with FDA expectations.”
If your question isn’t listed here, we’d be happy to assist you directly. Contact us today.
Quality Excellence Powered by Strategic Solutions
cGMP & FDA Compliance Consulting for Pharma, Biotech, Cell & Gene Therapy, Vaccines, CDMOs, and GMP Labs
📍 Sheridan, Wyoming Office
📞 +1-307-461-5690
📍 Raleigh, NC Office
📞 +1-919-297-2800
📧 Email: Info@AltabrisaGroup.com
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