Years Experience
Projects
Companies
Altabrisa Group Limited, LLC is a life sciences consulting firm specializing in GMP compliance, FDA readiness, and quality systems remediation. With over 20 years of experience in regulated environments, we serve pharmaceutical, biotech, cell and gene therapy, vaccine, CDMO/CMO, and GMP laboratory clients across the U.S. and internationally.
Our mission is simple:
To deliver practical, strategic compliance solutions that protect patients, improve operations, and reduce regulatory risk.
Founded by industry veterans, Altabrisa Group brings together former FDA-regulated professionals, auditors, and quality leaders who understand the real-world challenges of achieving and sustaining compliance.
We have led:
Every engagement starts with strategic alignment. We apply our proprietary AdaptiStrat™ Process to:
Conduct comprehensive audits and reviews. Identify areas of improvement and potential risks. Gather data to understand your unique challenges.
Collaborate to design customized approach. Create plan ddressing identified gaps and risks. Ensure alignment with regulatory requirements.
Deploy the new systems and processes. Provide training and support to your team. Monitor implementation and Adjust as necessary.
Regularly audit the new systems. Identify and address any issues or inefficiencies. Improve and enhance processes to maintain compliance.
Headquartered: Sheridan, Wyoming
Offices: Raleigh, North Carolina | Cancún, Mexico
Our consultants provide on-site and remote support across the U.S., Latin America, and select international markets.
When compliance is critical, you need more than consultants—you need strategic partners who understand what’s at stake.
Our team has decades of hands-on experience in FDA-regulated environments. We’ve supported successful inspections, recovered from warning letters, and led full-scale remediation efforts in pharma, biotech, cell therapy, and more.
We go beyond fixing isolated gaps. Our AdaptiStrat™ process delivers risk-based, scalable solutions that align compliance with operational performance—ensuring long-term success, not just inspection readiness.
We’re built for speed without sacrificing quality. Our solutions are realistic, implementable, and designed to reduce disruption while accelerating compliance outcomes.
From deviation backlogs and CAPA effectiveness to QMS design and FDA response writing—we specialize in the high-risk, high-impact areas that matter most.
With offices in the U.S. and Mexico, we serve clients across North America and Latin America, delivering personalized service and measurable results.
At Altabrisa Group, we don’t just offer solutions—we build strategies that work in the real world. Our proprietary AdaptiStrat™ Process is designed to help life sciences companies achieve and sustain GMP compliance through a structured, adaptive, and outcome-driven approach.
We begin every engagement with a thorough, risk-based evaluation of your quality systems, regulatory exposure, and operational context. This ensures that our recommendations are targeted and aligned with your business goals.
Not all gaps are equal. We focus on the issues that pose the highest risk to compliance, product quality, or patient safety. Our plans are tiered by urgency, impact, and feasibility—helping you allocate resources effectively.
We redesign or rebuild quality systems based on FDA expectations, industry best practices, and operational practicality. We streamline overly complex processes and bring clarity to roles, responsibilities, and documentation.
From drafting procedures to coaching teams, we stay engaged during execution. Our experts provide hands-on guidance, oversight, and troubleshooting to ensure that change takes hold across all levels of the organization.
We don’t just deliver a plan—we build internal capabilities. Through training, mentoring, and continuous feedback loops, we ensure your team is prepared to maintain compliance independently over the long term.
The AdaptiStrat™ Process isn’t a generic framework—it’s a strategic, purpose-built methodology designed for the complex needs of FDA-regulated life sciences organizations. It delivers measurable results where it matters most: compliance, speed, sustainability, and internal alignment.
We don’t treat every gap equally. AdaptiStrat™ targets the highest-risk compliance and quality issues first—maximizing regulatory impact and resource efficiency.
Unlike conventional remediation models, AdaptiStrat™ integrates compliance with operational strategy. We help you achieve inspection readiness without compromising speed, cost, or performance.
AdaptiStrat™ simplifies complex problems into actionable plans. With clear timelines, decision checkpoints, and escalation pathways, it accelerates deviation closures, CAPA effectiveness, and system updates.
Whether you’re preparing for an FDA inspection or managing a complex remediation, Altabrisa Group is ready to support you.
📧 info@altabrisagroup.com
📞 Raleigh Office: +1-919-297-2800
📞 Sheridan Office: +1-307-461-5690
Are you looking to improve your quality standards and ensure compliance in pharmaceuticals, biotechnology, vaccines, and cell and gene therapy industries?
Contact us today and schedule a free initial consultation with the experts at Altabrisa Group.
We offer personalized advice and strategies to help you develop, implement, and optimize your cGMP quality systems, ensuring your products meet the highest standards of safety and effectiveness.
Reach out to us today and take the first step towards excellence in quality and compliance.
