Quality audits are a cornerstone of pharmaceutical compliance and operational excellence. They not only ensure that your systems meet regulatory expectations—they reveal hidden risks, support continuous improvement, and prepare you for regulatory inspections. Whether you’re conducting internal audits, supplier audits, or preparing for a pre-approval inspection, a robust audit program is essential to maintaining control and trust.
At Altabrisa Group, we provide pharmaceutical, biotech, and advanced therapy companies with expert-led auditing services that go beyond checklists. We help you uncover real risks, identify gaps, and implement corrective strategies that drive sustainable compliance.
Regulatory authorities such as the FDA, EMA, and WHO expect life sciences companies to maintain an effective internal audit program as part of a compliant quality system (21 CFR 211.180, EU Annex 15, ICH Q10). Audits are no longer just about documentation—they are about demonstrating control.
Our AdaptiStrat™ Audit Process includes:
Our team includes industry experts, former auditors, and quality leaders with hands-on knowledge of FDA, EMA, and Health Canada expectations.
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We conduct comprehensive audits of your facility, processes, documentation, and systems to assess compliance with FDA 21 CFR Parts 210/211, EU GMPs, ICH Q10, and industry standards.
Your product is only as compliant as your supply chain. Altabrisa Group performs audits of suppliers, contract manufacturers (CMOs), API producers, testing labs, and packaging vendors—both on-site and remotely.
Whether you're preparing for a PAI, routine FDA inspection, or EU audit, we conduct mock inspections to assess readiness and identify weak points.
We help you build structured audit programs—from SOP development to auditor training and scheduling systems.
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Audits assess compliance with GMP regulations, uncover risks, evaluate system performance, and drive continual improvement.
Audit frequency should be based on risk, historical performance, and criticality.
A clear report should include the scope, methodology, findings (critical, major, minor), supporting evidence, and recommended corrective actions.
Yes. We provide both internal audits and independent third-party assessments of suppliers, partners, and outsourced operations.
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.
At Altabrisa Group, we bring over 30 years of hands-on experience in the life sciences industry. Our team of professionals specialize in pharmaceuticals, biotech, cell and gene therapy, and vaccines.
Our success is based on our unique Adaptistrat strategy to craft unique and personalized solutions in cGMP compliance.
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