Regulators Don’t Wait.... Neither Should You.

If your systems can’t pass inspection, you’re risking regulatory action, delays, and potential business disruption. 

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.

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.

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.

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.

Deviation & CAPA Backlog

  • Increased Regulatory Risk
  • Operational Inefficiency
  • Potential Compromised Quality
  • Resource Strain
  • Deviation & CAPA Backlog

  • Increased Regulatory Risk
  • Operational Inefficiency
  • Potential Compromised Quality
  • Resource Strain
  • Deviation & CAPA Backlog

  • Increased Regulatory Risk
  • Operational Inefficiency
  • Potential Compromised Quality
  • Resource Strain
  • How Our AdaptiStrat Process Works

    Step 1: Schedule a

    Consultation

    Fusce et varius justo. Morbi id dolor eget nisl porttitor ultricies ut at nisi. Aenean luctus in orci ut pretium. Nulla facilisi posuer velit nibh, eget aliquam nulla placerat eu pellentesque habitan morbi tristique senectus et netus et malesuada.

    Step 2: We do the

    work

    Fusce et varius justo. Morbi id dolor eget nisl porttitor ultricies ut at nisi. Aenean luctus in orci ut pretium. Nulla facilisi posuer velit nibh, eget aliquam nulla placerat eu pellentesque habitan morbi tristique senectus et netus et malesuada.

    Step 3: We do the

    work

    Fusce et varius justo. Morbi id dolor eget nisl porttitor ultricies ut at nisi. Aenean luctus in orci ut pretium. Nulla facilisi posuer velit nibh, eget aliquam nulla placerat eu pellentesque habitan morbi tristique senectus et netus et malesuada.

    Step 4: Enjoy the

    results

    Fusce et varius justo. Morbi id dolor eget nisl porttitor ultricies ut at nisi. Aenean luctus in orci ut pretium. Nulla facilisi posuer velit nibh, eget aliquam nulla placerat eu pellentesque habitan morbi tristique senectus et netus et malesuada.

    Step 5: Enjoy the

    results

    Fusce et varius justo. Morbi id dolor eget nisl porttitor ultricies ut at nisi. Aenean luctus in orci ut pretium. Nulla facilisi posuer velit nibh, eget aliquam nulla placerat eu pellentesque habitan morbi tristique senectus et netus et malesuada.

    What You'll Get with Altabrisa Group

    Quality Excellence, Powered by Strategic Solutions

    Feature

    Altabrisa

    Other Firms

    Real FDA Experience

    With Us

    With Them

    Deviation Backlog Reduction

    With Us

    With Them

    Client-Centric Partner Model

    With Us

    With Them

    Strategic Planning, Measurable Results

    With Us

    With Them

    On-Site CMO/CDMO Oversight

    With Us

    With Them

    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

    As Seen On

    Frequently Asked Questions

    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.

    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.

    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.

    Yes. We provide boots-on-the-ground oversight to ensure your contract manufacturing partners are compliant, controlled, and protecting your product and reputation.

    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.

    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.

    Articles & Information

    Struggling with FDA Compliance or cGMP Gaps?

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