Pharmacovigilance Solutions Excellence

Cloud Based Drug Safety Solutions

Our PV Solutions

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.

Pharmacovigilance Solutions

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
Pharmacovigilance Solutions
Pharmacovigilance Solutions

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
Pharmacovigilance Solutions

Our Pharmacovigilance curriculum is offered at Temple University, and we take pride in this accomplishment.

4C Pharma Solutions

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