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 Impact of Time-of-day-Dependent Administration of Nivolumab-Ipilimumab (ICI/ICI) Combination on Overall Survival in Adults With Advanced Kidney Cancer: A Pragmatic Multicenter, Randomized Controlled Trial.
Conditions: Advanced Kidney Cancer Interventions: Drug: Nivolumab & Ipilimumab; Drug: Nivolumab + Ipilimumab Sponsors: Guliz Ozgun; British Columbia Cancer Agency Not yet recruiting Conditions: Advanced Kidney Cancer Interventions: Drug: Nivolumab &...
Experiences w/ & Attitudes Towards Immune Chckpt Inhibitors in NSCLC Patients Single Center Survey Based Study
Conditions: Lung Non-Small Cell Carcinoma Interventions: Other: Non-Interventional Study Sponsors: University of Southern California; National Cancer Institute (NCI); Bristol-Myers Squibb Not yet recruiting Conditions: Lung Non-Small Cell Carcinoma Interventions:...
Experience of Staying in Intensive Care and Impact on Quality of Life
Conditions: Post-traumatic Stress Disorder Sponsors: University Hospital, Strasbourg, France Recruiting Conditions: Post-traumatic Stress Disorder Sponsors: University Hospital, Strasbourg, France Recruiting