FDAQRC
FDAQRC is a leading provider of regulatory compliance solutions for pharmaceutical, biotech, and medical device companies worldwide. They offer trusted compliance solutions, including quality audits, mock inspections, gap assessments, remediation services, recruitment, and more. With a global network of around 500 active consultants across 70+ countries, FDAQRC emphasizes personalized consulting, expertise across all GxP areas, and a client-centric approach. Their mission is to contribute to life science solutions using their technical expertise, aiming to improve global health and welfare through risk-based assessments and compliance excellence.
Industries
Nr. of Employees
small (1-50)
FDAQRC
Services
Execution of audits and mock inspections across GCP, GLP, GMP and related areas to evaluate compliance and identify corrective actions.
Development and implementation of remediation plans, CAPA, and inspection readiness activities to address findings and improve preparedness.
Custom QMS development including SOP drafting, governance and transition support for regulatory and ISO alignment, with emphasis on simplifying procedures to reduce non-compliance risk.
Validation of computerized systems and audits of electronic records to assess controls, data integrity, and compliance with electronic records regulations.
Support and advisory for pharmacovigilance practices, safety oversight and alignment with GVP requirements.
Qualified Person services to support compliant release and importation of pharmaceutical products into UK and EU markets.
Execution of audits and mock inspections across GCP, GLP, GMP and related areas to evaluate compliance and identify corrective actions.
Development and implementation of remediation plans, CAPA, and inspection readiness activities to address findings and improve preparedness.
Custom QMS development including SOP drafting, governance and transition support for regulatory and ISO alignment, with emphasis on simplifying procedures to reduce non-compliance risk.
Validation of computerized systems and audits of electronic records to assess controls, data integrity, and compliance with electronic records regulations.
Support and advisory for pharmacovigilance practices, safety oversight and alignment with GVP requirements.
Qualified Person services to support compliant release and importation of pharmaceutical products into UK and EU markets.
Expertise Areas
- Regulatory compliance across GxP
- Inspection readiness and auditing (including remote/virtual audits)
- Quality Management System (QMS) development and SOP simplification
- Computer system validation and electronic data integrity
Key Technologies
- Computer system validation (CSV)
- Electronic records compliance (21 CFR Part 11 and equivalents)
- Data integrity frameworks (ALCOA++)
- Decentralized clinical trial methodologies
News & Updates
FDAQRC is among the top 100 companies globally for rapid growth, recognized in the 19th annual Aggie 100.
FDAQRC commemorates 14 years of successful operations as of October 2023.
Marking 15 years of growth, global expansion, and commitment to quality and compliance.
Expert tips to turn audit stress into strategic success.
Exploring AI's role in clinical trials and regulatory silence on AI regulation.
Understanding roles and ensuring compliance in clinical research.
FDAQRC is among the top 100 companies globally for rapid growth, recognized in the 19th annual Aggie 100.
FDAQRC commemorates 14 years of successful operations as of October 2023.
Marking 15 years of growth, global expansion, and commitment to quality and compliance.
Expert tips to turn audit stress into strategic success.
Exploring AI's role in clinical trials and regulatory silence on AI regulation.
Understanding roles and ensuring compliance in clinical research.