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
Epidiolex Trial for Presymptomatic Treatment of Sturge-Weber Syndrome
Conditions: Sturge - Weber Syndrome (SWS) Interventions: Drug: Epidiolex 100 mg/mL Oral Solution Sponsors: Johns Hopkins University; Jazz Pharmaceuticals; Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Not yet recruiting Conditions: Sturge - Weber...
CERVICAL EPIDURAL BLOCK IN CHRONIC NECK PAIN
Conditions: Chronic Neck Pain; Cervical Radiculopathy Interventions: Procedure: Cervical Epidural Steroid Injection; Behavioral: Cervical Stabilization Exercise Program; Other: Physical Therapy Program Sponsors: Alİ Eman, MD Recruiting Conditions: Chronic Neck Pain;...
Transverse Perineal Support With STARR for Anterior Rectocele With Excessive Perineal Descent
Conditions: Rectocele; Perineal Descent Interventions: Procedure: STARR Procedure; Procedure: STARR combined with transverse perineal support procedure Sponsors: Cairo University Not yet recruiting Conditions: Rectocele; Perineal Descent Interventions: Procedure:...