At 4C Pharma Solutions, our Pharmacovigilance Solutions are carefully crafted to not only ensure drug safety but also to maintain regulatory compliance at every stage of product development and post-marketing. From start to finish, we provide comprehensive services, such as adverse event reporting, signal detection, risk management, and regulatory submissions. With our highly experienced team and advanced technology, we deliver seamless and compliant processes that enhance efficiency. Ultimately, we help pharmaceutical companies meet evolving global safety standards, all while prioritizing the protection of patient health.
Global & Local Literature Search
Case Processing
Electronic Submissions
Periodic Reports
Signal Detection
Risk Management
Medical Monitoring
Database Management
QPPV Support
We Strive to Serve Our Cause
Passion for Patient Safety” embodies our unwavering commitment to safeguarding the well-being of every patient. It not only signifies our dedication to implementing rigorous pharmacovigilance practices but also highlights our continuous efforts to monitor and assess the safety profiles of pharmaceutical products. Through our vigilant approach, we strive to ensure that patient safety remains at the forefront of everything we do.
Attributes of Our Solutions
Adverse Event Reporting Systems
These systems capture and analyze data related to adverse events associated with drugs.
Signal Detection and Management
This process involves analyzing data to detect potential safety signals and then managing those signals to determine if further action is necessary.
Risk Management Plans
These plans outline strategies to minimize the risks associated with drugs.
Post-Marketing Surveillance
This involves monitoring the safety of drugs once they are on the market.
Data Mining and Analysis
This involves the use of advanced data analysis techniques to identify potential safety issues.
Pharmacovigilance Training and Education
Providing training and education to healthcare professionals
Why Choose Us
Ongoing Support
- Safety Development Plan – SOP writing, Data
Migration, Implementation, Training - Case intake and Monitoring – Call centre
activities for AEs, PQCs and MI, Validity,
Duplicate check, Reportability, Triage - AE/ SAE/ processing – Data Entry, Coding,
Narrative Writing, Validation, Medical
Review, Submission, Follow-up, Compliance - Literature Search & Insights
Pre-defined Solutions Support
- Aggregate Reports – DSURs, PSURs, PADERs,
PBRERs - Signal detection, prioritization, evaluation
- Risk Management Plans (RMPs), REMS
- Social Media Analytics for PMS and
Spontaneous Adverse Events
Adhoc Solutions Support
- Medical Monitoring
- Risk-Benefit Assessment
- Regulatory Authority Requests, Audit/
Inspection readiness, mock-audits - Health Care Analytics
- Research Analytics and Insights
Our Pharmacovigilance curriculum is offered at Temple University, and we take pride in this accomplishment.
4C Pharma is a Comprehensive Healthcare Solutions Company specializing in end-to-end services of Pharmacovigilance, Materiovigilance, Medical Information Call Center, Safety Database Hosting, Regulatory Affairs & Medical Writing
Get In Touch
- 15 Corporate Place South, Suite 110, Piscataway, New Jersey, USA. 08854
- info@4cpharma.com
- +1 (732) 529-6989
