Regulators Don’t Wait.... Neither Should You.
If your systems can’t pass inspection, you’re risking regulatory action, delays, and potential business disruption.
- Fewer Deviations
- Operational Focus
- Inspection Ready
Over 200 Compliant Clients & Counting
Quality is Not in Control—And It’s Starting to Show
Deviations are piling up. CAPAs go nowhere. Inspections are looming, and your team is stuck reacting instead of leading. Leadership is asking tough questions. Compliance is slipping. And confidence—internally and externally—is wearing thin.
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Whether it’s lack of oversight, failed root cause analysis, or gaps at your CMO—what used to feel under control now feels like a liability.
We Help Quality
Take Back
Control.
Strategically.
We Help You Take Back Control.
Strategically.
We Help You Take Back Control
Strategically.
At Altabrisa Group, we don’t offer theory—we deliver action. We step in when compliance is slipping, quality systems are failing, and the pressure is on. From deviation backlog triage and CAPA effectiveness to audit preparation and CMO oversight, we bring clarity, structure, and compliance.
You’ll get strategic solutions built for ease of use and compliance, remediation that sticks, and a team that knows how to protect your product, your license, and your reputation.
Industries
Biotech
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Biotech
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Cell Therapy
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CDMO/CMO
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Vaccines
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Quality Laboratories
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Why partner
with
Altabrisa Group?
Why partner with Altabrisa Group?
Here's what you can expect....
Why partner with Altabrisa Group?
Here's what you can expect....
Client-Centric Partnership— Not Just Outsourcing
We work side by side with your team—not from a distance. Altabrisa Group is more than a vendor; we’re your quality partner. Our consultants embed with your staff, align with your priorities, and take shared ownership of your success from kickoff to closeout.
FDA-Level Expertise Without Big-Firm Overhead
You get senior consultants—including former FDA investigators and Tier I compliance experts—at lean, accessible rates. No bloated billing. No junior learning curves.
Strategic, Smarter Problem Solving That Sticks
We focus on root cause—not symptoms. We help eliminate recurring deviations, ineffective CAPAs, and systemic quality gaps so you can move forward with confidence.
How Our AdaptiStrat Process Works
Step 1: Schedule a
Consultation
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Step 2: We do the
work
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Step 3: Enjoy the
results
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What You'll Get with Altabrisa Group
Feature
With Us
With Them
Real FDA Experience
With Us
- 30+ years inside pharma, biotech, cell & gene
With Them
- Often staffing firms without real industy experience.
Deviation Backlog Reduction
With Us
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With Them
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Client-Centric Partner Model
With Us
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With Them
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Strategic Planning, Measurable Results
With Us
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With Them
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On-Site CMO/CDMO Oversight
With Us
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With Them
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What Our Clients Say About Us
Data Integrity
“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.”
Head of Quality, Startup Biotech Company
Deviation Backlog Reduction
“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.”
QA Director, U.S. Contract Manufacturer
Quality System Remediation
“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.”
VP of Quality, Cell Therapy Startup
What You'll Get with Altabrisa Group
Quality Excellence, Powered by Strategic Solutions
Feature
Altabrisa
Other Firms
Real FDA Experience
Altabrisa
30+ years inside pharma, biotech, cell & gene
Other Firms
Often staffing firms without real industy experience.
Deviation Backlog Reduction
Altabrisa
We reduce backlog, fix root cause, and prevent recurrence
Altabrisa
Only focused on closing deviations, not preventing re-occurrence
Client-Centric Partner Model
Altabrisa
We embed with your team and drive real change
Altabrisa
Detached and transactional
Strategic Planning, Measurable Results
Altabrisa
We strategically plan and deliver impact in weeks
Altabrisa
Long ramp-up, unclear ROI
On-Site CMO/CDMO Oversight
Altabrisa
We put boots on the ground to protect your product
Altabrisa
Remote-only or no third-party oversight
Articles & Information
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Frequently Asked Questions
What does Altabrisa Group specialize in?
Altabrisa Group provides FDA compliance consulting, cGMP remediation, quality system optimization, deviation and CAPA management, and audit readiness services for pharmaceutical, biotech, cell and gene therapy, vaccine, and CDMO/CMO organizations.
How is Altabrisa Group different from other consulting firms?
We don’t hand you a checklist—we partner with you to strategically plan, identify and remediate true root causes, embed with your team, and deliver real, inspection-ready results. With 30+ years of hands-on industry experience, we solve problems and build systems that last.
Who are your typical clients?
We work with executive teams, quality leaders, and regulatory departments at startups, midsize companies, and global manufacturers across the FDA-regulated life sciences sector. Whether you’re preparing for a FDA Audit, Remediating Quality Systems or cleaning up a 483, we can help.
Do you offer on-site support at our CMO or CDMO?
Yes. We provide boots-on-the-ground oversight to ensure your contract manufacturing partners are compliant, controlled, and protecting your product and reputation.
Can you help reduce our deviation backlog?
Absolutely. Deviation backlog triage and closure are one of our core strengths. We rapidly assess, prioritize, and eliminate backlogs while improving root cause analysis and CAPA effectiveness.
How quickly can you start supporting our team?
We move fast. After an initial call to understand your needs, we can often begin onboarding within days and deliver impact within weeks—whether you need a short-term fix or long-term compliance support.
