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
A Study Evaluating the Drug-Drug Interaction Between KL0011034 Injection and Alfentanil Hydrochloride Injection
Conditions: Chronic Pain Interventions: Drug: KL0011034 injection; Drug: Alfentanil Hydrochloride Injection Sponsors: Hunan Kelun Pharmaceutical Co., Ltd. Not yet recruiting Conditions: Chronic Pain Interventions: Drug: KL0011034 injection; Drug: Alfentanil...
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Conditions: Preoperative Anxiety; Orthopedic Surgery; Patient Reported Outcome (PRO) Interventions: Other: Enhanced Recovery After Surgery (ERAS) pathway; Other: Conventional care group Sponsors: Buddhist Tzu Chi General Hospital Recruiting Conditions: Preoperative...
Mindfulness Texting for Medication Adherence and Chronic Pain Management
Conditions: Opioid Use Disorder (OUD); Chronic Pain Interventions: Behavioral: Mindfulness text messages Sponsors: University of New Mexico; National Institute on Drug Abuse (NIDA) Recruiting Conditions: Opioid Use Disorder (OUD); Chronic Pain Interventions:...