Our Approach to GMP & FDA Compliance

Strategic. Scalable. Results-Driven.

At Altabrisa Group, we don’t just provide consultants—we bring structure, strategy, and execution to every quality engagement. Our proprietary AdaptiStrat™ Process was built from over two decades of real-world experience remediating FDA-regulated environments across pharmaceuticals, biotech, cell and gene therapy, CDMOs, vaccine production, and GMP laboratories.

We focus on solving the right problems the right way—quickly, sustainably, and in alignment with your business operations.

The AdaptiStrat™ Process: Our Proven
Methodology

  • ✅ Strategic Assessment
    We evaluate your compliance status, risk exposure, and QMS performance based on audit history, documentation, and site walk-throughs.
  • ✅ Gap Prioritization
    We identify high-risk findings and focus remediation efforts where they’ll have the greatest regulatory and operational impact.
  • ✅ System Redesign
    We update or rebuild SOPs, procedures, and roles to align with 21 CFR 210/211, ICH Q9/Q10, and global standards.
  • ✅ Implementation Support
    We don’t just advise—we execute. Our team works alongside yours to apply changes, train personnel, and manage rollout.
  • ✅ Sustainability & Readiness
    We build internal ownership, test effectiveness, and prepare your team for successful regulatory inspections.

Why It Works?

Our approach is built on decades of field experience—not theory. We’ve helped clients reduce deviation backlogs, close ineffective CAPAs, pass FDA inspections, and restore systems to a sustainable state of control.

Compliance Without the Chaos

Companies come to Altabrisa Group when inspections are approaching, systems are breaking down, or internal teams need support. Our structured, expert-driven approach delivers clarity, control, and measurable results.

Altabrisa Group Limited, LLC
1309 Coffeen Ave, Suite 832, Sheridan, WY 82801
📞 Raleigh Office: 919-297-2800
📧 Email: info@altabrisagroup.com

About Altabrisa Group Limited

Quality Excellence Powered by Strategic Solutions

our approach

We Understand Your Unique Challenges

At Altabrisa Group, we take the time to get to know your company and systems. 

Our focus is on building strong quality management systems. We help you manage deviations effectively, implement robust CAPA processes, and optimize change control. 

We also prioritize data integrity by introducing data integrity systems and governance practices that reduce human error and ensure the accuracy of critical information. 

This comprehensive approach not only helps you meet regulatory requirements but also enables you to make better decisions, driving your success in a competitive market.

What sets us apart is our commitment to partnership. We believe that working closely together leads to the best results. Building strong, trust-based relationships with our clients is at the heart of what we do. By collaborating with you, we make sure our solutions reflect your compliance goals. 

Benefits of Our Proven AdaptiStrat Process

Discover the key benefits of partnering with Altabrisa Group to navigate the complexities of the life sciences industry and achieve excellence in quality and compliance.

Mitigate Compliance Risks

Altabrisa provides strategic guidance and implements best practices. Our consultants work to foster a culture of compliance, maintaining your company’s reputation and operational stability.

Robust Quality Systems

Altabrisa Group develops and implements robust quality management systems that ensure consistent product quality and safety. Our comprehensive quality management processes address and prevent compliance issues.

Enhanced Data Integrity

We implement controls to minimize human error and establish rigorous data integrity and data governance frameworks. Our solutions ensure critical information is reliable and compliant throughout the product lifecycle.

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Contact Us Today to Discover
How We Work to Enhance Your Quality Systems

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.