Introduction
About CuraSafe Heathcare
Curasafe healthcare solutions Pvt. Ltd. provides comprehensive services including safety program oversight, risk management, and regulatory compliance.
Our expert team of safety medical Our drug safety physicians excel in medical review of Individual Case Safety Reports (ICSRs), aggregate reports, and signal management, as well as extensive support of Safety Medical Sciences, instilling rigorous product stewardship.
What We Do
Our Core Services
Curasafe healthcare solutions Pvt. Ltd. provides comprehensive services including safety program oversight, risk management, and regulatory compliance.
Drug Safety & Pharma co Vigilance
- ICSR management: All sources
- End to end Signal management
- Aggregate report writing: All type of reports
Quality Services
Our Services include:
- GxP Audits and Gap Assessments
- GxP Technical Consulting
- Quality Systems & Compliance
- Digital Transformation and Operational Excellence
- Computerized System Validation (CSV) and Data Integrity Management
- GMP and Technical Trainings
- Digital Operations: Improve compliance, speed to market and quality with CuraSafe advanced software and technology-elevated services.
Regulatory Affairs
We have a strong regulatory and scientific expertise. Key areas of expertise:
- Global clinical/regulatory strategy development Regulatory submissions and procedures Chemistry, manufacturing, and controls (CMC)
- Product information and labelling
- Regulatory informatics and regulatory operations services
- Lifecycle maintenance at global and local affiliate level
- Clinical trial applications (IND/CTA)
- eCTD services
Connect with Curasafe Healthcare Today
Reach out to us for detailed insights into our medical reporting services or to schedule a personalized consultation. Our team is ready to assist you with comprehensive surveys and analysis for your pharmaceutical needs.
Latest News
The Role of Inflammatory Biomarkers in Preventing Deep Sternal Wound Infections After Sternotomy
Conditions: Deep Sternal Infection; Diabete Mellitus; Mediastinitis Sponsors: Levan Nebieridze Active, not recruiting Conditions: Deep Sternal Infection; Diabete Mellitus; Mediastinitis Sponsors: Levan Nebieridze Active, not recruiting
Lower-Limb Muscle Mass and Cardiovascular and Muscular Performance in Males and Females
Conditions: Physical Performance; Leg Muscle Mass; Muscle Strength; Aerobic Capacity; Anaerobic Power; Jumping Performance in Young Adults Interventions: Other: Physical Performance Assessment Sponsors: Uludag University Not yet recruiting Conditions: Physical...
THE RELATİONSHİP BETWEEN BLOOD GAS PARAMETERS OBTAİNED FROM THE CORONARY SİNUS DURİNG THE PROCEDURE AND CRT RESPONSE İN PATİENTS WİTH HEART FAİLURE WHO UNDERWENT CRT IMPLANTATİON
Conditions: Heart Failure; Cardiac Resynchronization Therapy; Coronary Sinus Interventions: Diagnostic Test: coronary sinus blood sampling Sponsors: Trakya University Active, not recruiting Conditions: Heart Failure; Cardiac Resynchronization Therapy; Coronary Sinus...