In today’s highly regulated and rapidly evolving life sciences landscape, compliance is not just about avoiding penalties—it’s about building trust, ensuring patient safety, and fostering sustainable growth.
At Altabrisa Group, we specialize in delivering comprehensive compliance consulting services tailored for pharmaceutical, biotechnology, and medical device companies.
We provide strategic guidance and operational support across a wide range of regulatory and compliance areas:
FDA, EMA, MHRA, and global health authority regulations
GxP (GCP, GLP, GMP) audits and readiness
Quality systems implementation and optimization
Anti-kickback statute (AKS), False Claims Act (FCA)
Speaker programs and field force monitoring
Promotional materials and advertising review
Risk assessments and gap analysis
Code of Conduct development
Third-party due diligence and monitoring
Clinical operations SOP review and development
Investigator site audits and monitoring
Data integrity and transparency compliance (e.g., ClinicalTrials.gov, EU CTR)
HIPAA, GDPR, and global data protection regulations
Risk management and incident response planning
Vendor compliance and data sharing protocols
Deep Industry Knowledge: Our consultants bring decades of combined experience in life sciences compliance, regulatory affairs, and legal advisory.
Tailored Solutions: We don’t believe in one-size-fits-all. Each engagement is uniquely designed to fit your business model and risk profile.
Global Perspective: We support clients across North America, Europe, and Asia with multi-jurisdictional compliance strategies.
Actionable Insights: We deliver practical, business-aligned recommendations that help you move from reactive to proactive compliance.
“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.”
“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.”
“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.”
Data integrity serves as the backbone for compliance with current Good Manufacturing Practice (CGMP). Our quick guide delves into the intricacies of data integrity, offering actionable insights and best practices to uphold the highest standards of quality and regulatory compliance.
