Anacon Research | Assessing & Assisting Compliance

Our Pharmacovigilance (PV) services provide comprehensive drug safety solutions to ensure continuous monitoring, assessment, and reporting of adverse events throughout the product lifecycle. We support pharmaceutical, biotechnology, medical device, and healthcare companies in meeting global regulatory requirements while safeguarding patient safety and maintaining product compliance.

Our experienced pharmacovigilance professionals deliver end-to-end safety management services in accordance with international regulatory guidelines, including ICH, GVP, US FDA, EMA, MHRA, CDSCO, and other global health authorities.

Our Pharmacovigilance Services Include:

Individual Case Safety Report (ICSR) Management

Adverse Event (AE) and Serious Adverse Event (SAE) processing
Medical review and case assessment
Coding using MedDRA and WHO Drug Dictionary
Narrative writing and quality review
Expedited reporting to regulatory authorities

Aggregate Safety Reporting

Periodic Safety Update Reports (PSUR/PBRER)
Development Safety Update Reports (DSUR)
Periodic Adverse Drug Experience Reports (PADER)
Risk evaluation and benefit-risk assessment

Signal Detection & Risk Management

Signal identification and validation
Signal evaluation and documentation
Risk Management Plans (RMP)
Benefit-risk analysis and recommendations

Literature Surveillance

Global and local literature monitoring
Scientific article screening
Case identification and reporting
Regulatory literature compliance

Pharmacovigilance System Support

Pharmacovigilance System Master File (PSMF)
Standard Operating Procedures (SOPs)
Safety database management
Quality management and compliance documentation

Medical Information & Safety Support

Medical inquiry handling
Product complaint management
Pregnancy exposure reporting
Special situation case management

Regulatory Compliance & Audits

PV system gap assessments
Pharmacovigilance audits
Inspection readiness
CAPA development and implementation
Vendor qualification and oversight

Clinical Trial Safety

SAE reconciliation
SUSAR reporting
Investigator safety communications
Clinical safety monitoring support

Why Choose Anacon Research?

Experienced pharmacovigilance physicians, pharmacists, and life science professionals
Compliance with ICH-GCP, GVP, FDA, EMA, MHRA, CDSCO, and global regulatory standards
Robust quality systems and validated processes
Timely case processing and regulatory submissions
Flexible, scalable, and cost-effective solutions
Dedicated support across clinical development and post-marketing surveillance

Our pharmacovigilance services help clients proactively monitor product safety, manage regulatory obligations, minimize compliance risks, and protect patient health while ensuring the highest standards of drug safety throughout the product lifecycle.

Pharmacovigilance Services