One Step Ahead
Why We Are The Best Pharmacovigilance and drug safety solution provider
Ensuring the best pharmacovigilance and drug safety services!
4C is run and managed by medical doctors who have evolved from the Industry of Clinical Research and Pharmacovigilance Solutions or Pharmacovigilance (PV) Outsourcing. With handpicked best talents from the industry and trained them on robust 4C curriculum to deliver best in class service and experience to our Small, Medium and Large pharma clients. 4C excels in providing end to end effective monitoring of safety and efficacy for Drugs, Devices, Cosmetics, Biological, Consumer Products, Cannabinoids, Veterinary & Nutraceuticals
A Holistic approach to our customers needs
- Medical Information Call Centre
- Follow up with reporters
- Literature Search
- In-House Argus
- Automated MICC Software
- Case Processing
- Quality Check
- Medical Review
- Paper, SRP, ESG Submissions
- PI/IRB Submissions
- Periodic Reports
- QPPV Support
- Signal Management
- Regulatory Intelligence
- Risk Management
- Data Quality Management
- PMS and PASS
- Reconciliation
- Metrics Management
- PV Audit Preparation
360 degree
Pharmacovigilance Solutions
Explore What We Are Doing Better
ONGOING SUPPORT
Case Intake and Monitoring
Signal Detection, Prioritization, Evaluation
PREDEFINED SUPPORT
Medical Monitoring
Risk-Benefit Assessment
ADHOC SUPPORT
Regulatory Authority Requests, Audit/ Inspection
Health Care Analytics
VETERINARY
Pharmacovigilance Solutions
4C is equipped to support adverse events report of animal health data to the EMA and all EU Competent Authorities using the EUVeterinary guidelines as well as HL7 compliant system required by the FDA’s Center for Veterinary Medicines and as defined by the VICH.
Veterinary
Pharmacovigilance Solutions
Veterinary pharmacovigilance is defined in Article 73 of Directive 2001/82/EC covers not only the safety aspects in animals and in humans related to veterinary medicinal products, but also other aspects of post-authorization surveillance. The system also considers any available information arising from the use of veterinary medicinal products, such as:
- Lack of expected efficacy of veterinary medicinal products
- Adverse reaction reports related to off-label use
- Reported violations of approved residue limits, possibly leading to investigations of the validity of the withdrawal period
- Potential environmental Problems
Case Processing
Literature Search
Field Alert Reports
Serious Adverse Reaction Reports in Animals
Reports of Adverse Reactions in Humans
Adverse Drug Events Reports and PSURs
Report Submission
Reporting
Medical Information Call Center
Pharmacovigilance Systems have been moving towards better environment and better reporting platforms. This change was initiated by EMA which is accepting E2B(R3) reports from 22-Nov-2017.
