FDA Compliance, Quality Systems, and Strategic Remediation for Pharmaceutical Manufacturers
Altabrisa Group provides pharmaceutical manufacturers with hands-on consulting to resolve compliance gaps, strengthen quality systems, and prepare for regulatory inspections. With over 20 years of experience in FDA-regulated environments, we help companies navigate complex GMP challenges across oral solid dose, sterile, biologics, and combination product manufacturing.
Whether you’re responding to a 483, addressing an ineffective CAPA program, or preparing for a pre-approval inspection, we bring structure, urgency, and clarity to every engagement.
We support pharmaceutical manufacturers across development, commercial production, and contract manufacturing operations. Our team brings deep expertise in U.S. and global regulatory expectations—including 21 CFR 210/211, ICH Q9/Q10, and WHO GMP.
✅ Deviation Management & Investigation Support
We reduce backlogs, improve root cause quality, and ensure investigations are complete, compliant, and closed on time.
✅ CAPA Effectiveness
We build robust CAPA programs that drive real corrective action—no more repeat issues or ineffective responses.
✅ QMS Design & Remediation
We stabilize and modernize Quality Management Systems to align with current regulatory expectations and business operations.
✅ FDA Inspection Readiness & Response
We prepare your site for FDA inspections and guide you through response strategies that reduce enforcement risk.
✅ Quality Oversight & Person-in-Plant Support
We provide on-site support, coaching, and leadership when internal bandwidth or expertise is limited.
We help pharmaceutical manufacturers fix the root cause—fast—and implement systems that hold up to FDA scrutiny.
Pharmaceutical companies trust Altabrisa Group when compliance is at risk, systems are breaking down, or internal teams need backup. Whether you need short-term support or long-term transformation, we bring clarity and execution where it matters most.
Altabrisa Group Limited, LLC
1309 Coffeen Ave, Suite 832, Sheridan, WY 82801
📞 Raleigh Office: 919-297-2800
📧 Email: info@altabrisagroup.com
Altabrisa Group delivers expert pharmaceutical consulting to help manufacturers meet FDA and global GMP expectations. Whether you’re under remediation or scaling production, our team provides strategic support to strengthen quality systems, improve documentation, and reduce regulatory risk.
Altabrisa Group also provides quality consulting and remediation services for the pharmaceutical industry. This includes deviation management, CAPA management, data governance, and data integrity consulting. They help clients establish quality management systems that comply with current industry regulations, guidelines, and standards.
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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.
By choosing to partner with Altabrisa, your company benefits from a adaptable, specific approach designed to mitigate compliance complexities and secure your company’s future in the competitive life sciences industry.
Our focus is on building strong quality management systems. We help you manage deviations effectively, implement robust CAPA processes, and optimize change control.
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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.
Quality Excellence Powered by Strategic Solutions
cGMP & FDA Compliance Consulting for Pharma, Biotech, Cell & Gene Therapy, Vaccines, CDMOs, and GMP Labs
📍 Sheridan, Wyoming Office
📞 +1-307-461-5690
📍 Raleigh, NC Office
📞 +1-919-297-2800
📧 Email: Info@AltabrisaGroup.com
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