Your Proactive Safety Partner
True success in pharmacovigilance requires a partner that functions as a true ally, anticipating your needs and treating your project as if it were our only project.
Unwavering Quality & Compliance
We start with the fundamentals. Our systems and processes are built on a foundation of quality, efficiency, and steadfast adherence to global regulations (FDA, EMA, MHRA, ICH).
Responsive & Flexible Partnership
We analyze how our team responds to your individual needs and ad hoc requests, ensuring a cultural fit and a long-term partnership where you are understood and prioritized.
Proactive Strategic Guidance
Are we moving forward to be ready for a potential expedited submission? Are efficiency ideas shared proactively? We stay ahead of regulatory changes to protect your project's future.
These operations are the muscle. IHASG is the governance.
Full-service PV execution sits beneath Integrated High-Acuity Safety Governance — the physician-led, documented, inspection-ready oversight layer built for AI-assisted and real-time trials.
End-to-End Pharmacovigilance Solutions
From first-in-human trials through global post-marketing surveillance, our specialists provide a full suite of services to ensure your PV system fulfills all regional and global regulations.
1. Clinical & Post-Marketing Case Management
Comprehensive Case Processing: Subject matter expertise for all case types including clinical trial SAEs, AESIs, pregnancies, serious and non-serious spontaneous/solicited cases, literature, social media, and legacy cases.
End-to-End Workflow: Our process includes case intake, data entry, MedDRA & WHO Drug coding, narrative writing, quality control, physician medical review, follow-up, and reconciliation.
Plaintiff Fact Sheet (PFS) & Medical Record Packet (MRP) Processing: A specialized, large-scale service for processing legal case documents, including intake, coding, physician assessment, narrative generation, and regulatory reporting for cases involved in legal disputes.
2. Global Safety Infrastructure & Governance
Global Safety Database: A fully compliant and validated, multi-tenant Oracle Argus safety database as a single source of truth. We offer client-specific modifications, direct read-only access, and expert data migration services. Single-tenant solutions are also available.
- ►Provision of experienced EU Qualified Person for Pharmacovigilance (QPPV).
- ►Global network of Local Persons for Pharmacovigilance (LPPV) in over 50 countries, including national-specific roles like Germany's "Stufenplanbeauftragter".
- ►Establishment and maintenance of the MAH's PV system, serving as the 24/7 point of contact for Competent Authorities.
3. Signal Management & Risk Mitigation
Proactive Signal Detection: A critical process for timely identification of potential new safety risks. We utilize data from spontaneous cases, clinical trials, non-interventional studies, and literature reports.
Expert Signal Management Lifecycle: Deep expertise across all signal activities, including detection, validation, prioritization, and assessment.
EudraVigilance Data Analysis System (EVDAS): Fully trained and experienced in EVDAS to support MAHs in complying with their signal detection and management obligations.
Global Literature Review: Cost-effective global and local literature screening of large bibliographical databases (e.g., Medline®) to identify reportable ICSRs and potential safety signals.
4. Aggregate Reporting & Risk Management Plans
- ►Development Safety Update Reports (DSURs)
- ►Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs)
- ►Periodic Adverse Drug Experience Reports (PADERs)
- ►Country-specific periodic reports
Risk Management Plans (RMP / REMS): Expert support for the preparation and maintenance of RMPs and Risk Evaluation and Mitigation Strategies (REMS) for innovators, generics, biosimilars, and combination products.
Regulatory Response Support: Assisting with responses to Requests for Information (RFI) from Regulatory Authorities and preparing the Addendum to Clinical Overviews (ACO).
5. Global Submissions & Regulatory Intelligence
Global ICSR Submissions: Accurate and on-time submissions (>99% compliance rate) to health authorities, IRBs, and ECs. Expertise in MedWatch, CIOMS I, E2B(R2), and E2B(R3) formats for all product types.
Proprietary Regulatory Intelligence (RI): Our submission process is built on our own comprehensive database of global Safety RI, developed using RI tools, manual searches, and local experts.
Flexible RI Service Models: We offer tiered access to our PV RI database and updates, from providing regulatory tables to full RI consultant support.
Physician-Led Safety Oversight
Our PV services are guided by experienced physicians with deep expertise in clinical safety, benefit-risk assessment, and regulatory strategy.
Dr. Ashok Srivastava
A proven leader in global clinical safety governance. Dr. Srivastava has collaborated directly with FDA, EMA, and other health authorities on safety signals and has authored safety content for numerous regulatory dossiers and briefing materials.
Discover our broader KOL & Expert Network →Elias Tharakan
Pioneer of a "Compliant AI" framework that integrates advanced technology with stringent regulatory requirements. Elias ensures our PV systems are not only robust and scalable but also intelligent and forward-looking.
Ready to build your inspection-ready PV system?
Physician-led pharmacovigilance, backed by IHASG safety governance and the Medical Oversight Workbench.