At FicusRealtime, we specialize in helping organizations respond effectively to regulatory audit findings and implement lasting compliance improvements. Whether you're facing an FDA 483, MHRA observation, CDSCO non-compliance report, or internal GMP audit, our experts guide you through a structured and compliant response strategy.
At FicusRealtime, we provide end-to-end support in responding to regulatory audit findings and ensuring full compliance with industry standards. Our expert team works closely with your Quality and Compliance departments to help you address observations, implement corrective actions, and prepare for successful re-audits.
1. Observation Analysis:
We perform a detailed review of each audit observation, evaluating risk, root cause, and potential impact on compliance.
2. CAPA Development:
Our specialists create Corrective and Preventive Actions that are realistic, risk-based, and aligned with global regulatory standards.
3. Response Letter Drafting:
We help you craft professional response letters that reflect accountability, corrective measures, and a strong compliance mindset.
4. Implementation & Monitoring:
FicusRealtime ensures smooth implementation of CAPAs, SOP revisions, system improvements, and ongoing monitoring.
5. Closure Support:
We support you during re-inspections or regulator follow-up by compiling evidence and readiness documentation.
Industry-Specific Software for Enhanced Quality and Compliance
Testimonials
20K+ Satisfied Clients World Wide
Deployed a Professional team and Accomplished The Successfull completion of the CSV Project with in our Organization.They Delivered a High Quality out for Chromotography and purified Water System Integrated with PLC-HMI Systems All while ensuring strict adherence to Regulatory standards.
MANGALAM ORGANICS LIMITED
VINS BIOPRODUCTS LIMITED
ORCH LABORATORIES INDIA PVT.LTD
EXTROVIS PRIVATE LIMITED
ISO QUALITY MANAGEMENT SYSTEM
NSJ PRAYOG LIFE SCIENCES PVT.LTD
