Pharmacovigilance (PV) Services
At Paraclete Technologies, we offer comprehensive Pharmacovigilance (PV) services to ensure the safety and effectiveness of pharmaceutical products throughout their lifecycle. Our experienced team helps pharmaceutical companies comply with global regulatory standards by providing expert support in monitoring, assessing, and preventing adverse effects. From clinical trials to post-market surveillance, our PV services safeguard patient health while ensuring regulatory compliance.
Do You Know?
What is Pharmacovigilance?
Pharmacovigilance (PV) refers to the science and activities related to detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. It plays a critical role in ensuring the safety of medicines and protecting public health, as well as fulfilling regulatory requirements from authorities like the FDA, EMA, and others.
What We Offer?
Our Pharmacovigilance Services
Adverse Event Reporting & Management
We manage the end-to-end process of adverse event reporting, from data collection to submission to regulatory authorities. Our team ensures timely and accurate reporting of all adverse events, enabling compliance with local and international regulations.
Signal Detection & Risk Management
We monitor safety data to detect potential signals of adverse events and other risks. By analyzing safety trends and potential issues, we help clients develop risk management plans to minimize harm and enhance patient safety.
Case Processing
Our expert team handles the intake, review, assessment, and processing of individual case safety reports (ICSRs) to ensure compliance with PV regulations. We prioritize accuracy and timeliness in case processing for regulatory submissions.
Aggregate Reporting
We provide periodic and aggregate safety reports, including Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs), which summarize product safety data over specified intervals to keep regulators informed.
Audits and Inspections
We conduct internal audits and prepare your organization for regulatory inspections. Our audits ensure that your pharmacovigilance systems and processes meet global regulatory requirements, helping you stay compliant and audit-ready.
Support and Consultation
We offer expert guidance and support for all aspects of pharmacovigilance compliance, including submissions to regulatory authorities and responding to regulatory queries. Our team ensures that your PV activities are fully aligned with evolving regulations.
Why Choose Us?
Trusted IT Solution & Service Business Company
Expertise
Our team consists of skilled developers with extensive experience
Quality Assurance
Our Aim is to quality means we conduct thorough testing
Custom Solutions
We understand that every business is unique.