Pharmacovigilance Services
Strengthen Your Drug Safety Framework with DDReg’s Technology-Driven Pharmacovigilance Solutions. DDReg streamline safety database operations and leverage advanced technologies to deliver efficient, risk-minimized pharmacovigilance systems. Our global team of pharmacovigilance consultants ensures end-to-end support in ICSR Processing and Submission, enabling the delivery of compliant, audit-ready solutions that enhance drug safety and protect patient well-being.
DISCOVER MOREICSRs
Aggregate Reports
RMPs
ADCO/AASRs
Tailored and Compliant Pharmacovigilance Solutions for Drug Safety
DDReg offers tailored PV solutions designed to proactively identify potential safety signals and emerging trends in post-marketing drugs. By leveraging advanced AI tools, our pharmacovigilance systems ensure the highest standards of drug and patient safety. Our processes are built to be fully compliant with international standards such as ICH and GVP and adhere to regulations established by global authorities like the US FDA, EMA, and UK MHRA.
As a reputed provider of drug safety and pharmacovigilance services, our integrated approach covers every stage of the safety data lifecycle. From initial ICSR case processing using E2B(R3) compliant databases integrated with MedDRA and WHO DD coding to literature monitoring (including EMA’s Medical Literature Monitoring) and risk management, our systems deliver seamless, end-to-end support. Our methodologies extend to compiling and quality-checking Risk Management Plans (RMPs) and Risk Evaluation Mitigation Strategies (REMS), ensuring a comprehensive solution.
Comprehensive Drug Safety and Pharmacovigilance Operations
Our team of medico‐regulatory experts and safety writing specialists is dedicated to managing all drug safety operations. We support the authoring and compilation of pharmacovigilance aggregate reports such as Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Periodic Benefit Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs). In addition, our QPPV services include reviewing SDEA agreements, handling QPPV/RPPV and PSMF updates, retainer services, and medical surveillance for effective signal management.
Our comprehensive service suite encompasses a broad range of operations—from ICSR processing and submission to literature monitoring, risk management, audit and compliance, and signal management. We support global pharmaceutical companies by developing and maintaining robust pharmacovigilance systems through the implementation of standard operating procedures (SOPs), quality management systems, and pharmacovigilance system master files (PSMFs). These initiatives ensure our clients achieve seamless regulatory compliance and maintain the highest level of pharmacovigilance safety.
Our Pharmacovigilance Services
01
ICSR Case Processing and Submission
Our advanced Individual Case Safety Report (ICSR) Pharmacovigilance Services are dedicated to ensuring patient safety through precise case handling....
02
Literature Monitoring
DDReg’s Literature Monitoring Services offer advanced pharmacovigilance literature screening for drug safety. We help Marketing...
03
Risk Management
Our expert risk management solutions ensure patient safety by proactively addressing potential hazards in pharmaceutical...
04
Audit and Compliance
Our specialized services ensure that pharmacovigilance systems across the drug development pipeline meet strict regulatory...
05
Pharmacovigilance Signal Management Services
DDReg’s specialized pharmacovigilance services ensure that potential adverse events are identified and addressed promptly...
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QPPV Services
DDReg’s expert team provides comprehensive QPPV services designed to strengthen your pharmacovigilance system. We ensure that...
