FAQ’s – FDA & cGMP Compliance Consulting

FAQs

Find clear, concise answers to the most common questions about our FDA compliance and GMP consulting services. If you d

Q1: What industries does Altabrisa Group support?

A: We support pharmaceutical, biotech, cell & gene therapy, vaccine, CDMO/CMO, and GMP laboratory clients.

Q2: Where is your team located?

A: We operate globally, with offices in North Carolina, Wyoming, and Cancun, Mexico. We support both remote and on-site

Q3: Do you provide support during FDA inspections?

A: Yes. We offer Person-in-Plant (PIP) support, mock audits, and real-time FDA inspection readiness services.

Q4: What is the AdaptiStrat™ Process?

A: It’s our proprietary approach to compliance: Diagnose → Design → Deliver. Each engagement is tailored to regulatory ri

Q5: Can you help us respond to a 483 or Warning Letter?

A: Absolutely. We specialize in remediation strategy, CAPA planning, and implementation support for FDA enforcement act

Q6: What is the typical length of a consulting engagement?

A: It depends on your needs. Some projects are as short as 2 weeks, while full-scale remediations may run 6–18 months.

Q7: How do we get started with Altabrisa Group?

A: Book a 30-minute consultation through our booking page or email us at info@altabrisagroup.com.

Q8: Do you offer a free consultation?

A: Yes. Our initial strategy session is complimentary and intended for decision-makers evaluating GMP and FDA complianc

Q9: What types of companies do you typically work with?

A: We serve startups, mid-sized firms, and global organizations across the regulated life sciences sector.

If your question isn’t listed here, we’d be happy to assist you directly. Contact us here or call +1-919-297-2800 (North Carolina