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
Probiotics for Depressive Symptomatology and Neural Activity.
Conditions: Mild-to-moderate Depression; Neural Activity; Executive Function (Cognition) Interventions: Dietary Supplement: Ecologic® Barrier; Dietary Supplement: Placebo powder Sponsors: University of Reading; Winclove Probiotics B.V. Not yet recruiting Conditions:...
Colistin Nephrotoxicity and Role of Alpha Lipoic Acid
Conditions: Nephrotoxicity Interventions: Drug: alpha lipoic acid drug (thioctic acid acid) Sponsors: Helwan University Not yet recruiting Conditions: Nephrotoxicity Interventions: Drug: alpha lipoic acid drug (thioctic acid acid) Sponsors: Helwan University Not yet...
Efficacy and Safety of SP16 in Preventing Acute Kidney Injury in At-risk Subjects With Chronic Kidney Disease Undergoing Elective Cardiac Surgery Using the Heart-lung-machine
Conditions: AKI - Acute Kidney Injury Interventions: Drug: SP16-3M; Drug: Placebo Sponsors: University of Erlangen-Nürnberg Medical School; Serpin Pharma, LLC Not yet recruiting Conditions: AKI - Acute Kidney Injury Interventions: Drug: SP16-3M; Drug: Placebo...