The Quantic Group
The Quantic Group® is a pharmaceutical, biotechnology, vaccines, and medical device specialty consultant supporting clients globally in regulatory, research, development, manufacturing, and quality operations. With over 30 years of experience, they focus on managing regulatory enforcement actions, including FDA consent decrees, and provide expertise in business strategies, organizational structures, compliance programs, and regulatory matters.
Industries
Nr. of Employees
small (1-50)
The Quantic Group
Livingston, New Jersey, United States, North America
Services
Consulting to remediate regulatory findings, manage consent decrees, and certify progress to agencies.
Preparation of regulatory dossiers and support for pre-approval inspections and submission readiness.
Operational and regulatory audits, facility inspections, risk assessments, and due diligence for transactions or compliance programs.
Design and evaluation of clinical studies, pharmacovigilance system development, and safety process implementation.
Review of laboratory systems, analytical methods, and data integrity to ensure accuracy and regulatory compliance.
Development and execution of validation protocols for facilities, equipment, processes, and batch records.
Consulting to remediate regulatory findings, manage consent decrees, and certify progress to agencies.
Preparation of regulatory dossiers and support for pre-approval inspections and submission readiness.
Operational and regulatory audits, facility inspections, risk assessments, and due diligence for transactions or compliance programs.
Design and evaluation of clinical studies, pharmacovigilance system development, and safety process implementation.
Review of laboratory systems, analytical methods, and data integrity to ensure accuracy and regulatory compliance.
Development and execution of validation protocols for facilities, equipment, processes, and batch records.
Expertise Areas
- Regulatory compliance and remediation
- Quality systems and compliance programs
- Clinical trial management and pharmacovigilance
- Bioequivalence and clinical study evaluation
Key Technologies
- Process Analytical Technology (PAT)
- Bioequivalence testing methods
- Clinical trial design and biostatistics
- GMP manufacturing practices