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
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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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