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
Hyaluronic Acid and Polynucleotides in Ridge Preservation
Conditions: Socket Preservation; Implant-supported Single Crowns; Hyaluronic Acid; CAD-CAM Interventions: Device: regeneration of post extraction socket with biomaterials Sponsors: University of Parma; Geistlich Pharma AG Recruiting Conditions: Socket Preservation;...
A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma
Conditions: Asthma Interventions: Drug: SHR-1905 Injection; Drug: SHR-1905 Placebo Injection Sponsors: Guangdong Hengrui Pharmaceutical Co., Ltd Not yet recruiting Conditions: Asthma Interventions: Drug: SHR-1905 Injection; Drug: SHR-1905 Placebo Injection Sponsors:...
A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma.
Conditions: Advanced Melanoma Interventions: Drug: LBL-024 for Injection; Drug: LBL-007 Injection; Drug: Toripalimab Injection Sponsors: Nanjing Leads Biolabs Co.,Ltd Not yet recruiting Conditions: Advanced Melanoma Interventions: Drug: LBL-024 for Injection; Drug:...