ICG delivers PSUR, DSUR, and PBRER writing for Indian and global pharmaceutical companies — ICH E2C and ICH E2F compliant, audit-ready by design, with 4-layer sequential QC on every deliverable. Built by IIT BHU pharmaceutical engineers who understand the science behind the report — not just the template.
Aditi responds within 4 business hours · ICH E2C · ICH E2F · EURD · DLP-specific protocols
PSUR/DSUR dates are set by regulators and data lock points — not by how much your team has on its plate. When a DLP falls in the same month as two other deliverables, internal capacity doesn't expand to meet it. The deadline stays fixed. The gap between workload and capacity becomes a compliance risk.
A newly approved product needs its first PSUR. The safety data exists. The literature search protocol needs to be designed. The narrative architecture needs to be built from scratch. The first PSUR sets the template for every one that follows — building it wrong creates years of remediation work.
An inspection flagged a reproducibility issue with literature search methodology. Or a narrative gap. Or an inconsistency between the PSUR and the signal evaluation section. The remediation window is short. The standard of the next submission must be demonstrably higher.
ICG has been the external partner for all three scenarios. The first call is a scoping conversation — no commitment. WhatsApp ICG to start it →
Periodic Safety Update Report. Full E2C(R2) structure — worldwide marketing authorisation status, actions taken for safety reasons, changes to reference safety information, patient exposure, literature, ongoing studies, signal evaluation and overall safety evaluation. Literature search protocol included.
Development Safety Update Report for investigational products. Annual safety reporting for drugs in clinical development. Integrates clinical trial safety data, IND annual reports, and Development Core Safety Information. SUSAR line listings and reconciliation included.
Periodic Benefit-Risk Evaluation Report — the PSUR format required by EMA and adopted by multiple global regulators. Structurally aligned with PSUR but with explicit benefit-risk integration sections. Same 4-layer QC architecture as all ICG deliverables.
Reproducible PubMed search protocol for periodic safety reporting. MeSH headings and TIAB fields. Drug name variants captured. De-duplication methodology documented. Audit-traceable from search string to included article. Powered by Pharos Scout.
Most PSUR writing failures are not scientific failures — they are process failures. A literature search that isn't reproducible. A narrative that doesn't connect to the signal evaluation. A benefit-risk section written last without reading the interval analysis first. ICG's Publication Readiness System™ engineers these failures out before they reach a regulator.
DLP confirmed. Submission deadline confirmed. Regulatory market(s) confirmed (India CDSCO, EU EMA, US FDA, ROW). Previous PSUR reviewed if available. Data sources confirmed: safety database, lit search, clinical trial data, post-marketing surveillance.
Search strings constructed per drug-AE combination. MeSH headings and TIAB fields. Drug name variants. Protocol signed off by client before search runs. Powered by Pharos Scout — results de-duplicated, scored by evidence quality, exported audit-ready.
Cumulative and interval case data analysed. Line listings reviewed. Signal evaluation framework applied. Benefit characterisation and risk characterisation drafted before narrative writing begins — so the narrative reflects the data, not vice versa.
Full PSUR/DSUR/PBRER to ICH E2C(R2)/E2F structure. Every claim traceable. Every signal supported. Version control from first draft.
Draft delivered with tracked changes. All comments addressed in consolidated response document. Final version delivered submission-ready.
Every PSUR ICG writes uses Pharos Scout for the literature search — our adverse-event-driven surveillance platform that auto-generates validated PubMed search queries, de-duplicates results, scores articles by evidence quality, and produces audit-traceable search logs that survive an inspection.
Pharos Scout · Validated MeSH + TIAB queries · Audit-ready logs
ICG's Co-Founding Team and pharma practice lead are pharmaceutical engineers from IIT BHU's Department of Pharmaceutical Engineering and Technology — B.Tech and M.Tech graduates who have studied drug metabolism, formulation science, pharmacokinetics, and clinical pharmacology.
This is not a credential for a website. It is the reason why ICG manuscripts have fewer scientific errors in medical review, why ICG PSURs have fewer clarification cycles, and why the scoping call for a literature monitoring engagement sounds different from every other agency you've briefed. The science is understood before the brief is written.
Every pharmacovigilance engagement ICG runs is powered by Scout, Vigil, and Deploy — three tools built for the specific frictions of PV operations that no off-the-shelf tool solves.
Explore the full Pharos platform →AI Scientific Writing
AI-guided manuscript development from topic selection to submission-ready output. Journal fit intelligence. CONSORT/PRISMA embedded from Day 1.
Literature Monitoring
Adverse-event-driven literature surveillance. Validated PubMed queries. De-duplication. Evidence scoring. Audit-ready search logs.
PV Resource Allocation
Risk-based drug tiering and defensible PV staffing. Objective tier from signal frequency and seriousness. Headcount you can defend with data.
Drug AE Intelligence
Single-drug adverse event visualization dashboard. On-demand data refresh. Spot signals before they escalate.
Prescription Intelligence
HCP-level prescription intelligence. Visit history, AI call analysis. See Rx switching risk before it moves.
Explore RxFlow →MR Route Optimization
AI route planning for medical representatives. Priority-scored daily call plans. Right HCP, right day, every day.
Explore RouteIQ →Sales Pipeline Intelligence
Stagnation alerts before deals go cold. Stage bottleneck heatmaps. Intervene before it's too late.
Explore Gate →MR AI Coaching
AI coaching after every HCP visit. Post-visit feedback, objection analysis. Turn each visit into a prescription.
Explore Signal →Pharma MIS Command Centre
360° commercial intelligence for leadership. Revenue, field force, distributor, market — one real-time view.
Explore Pulse →Every ICG pharma engagement runs on some combination of these nine modules. The pilot engagement determines which ones are active from Day 1.
Start a pilot project →Every ICG pharma engagement is led personally by Aditi Tripathi — M.Pharm, IIT BHU — with Abhash, Deep and Rohit (Co-Founding Team) bringing the scientific rigour, delivery architecture and commercial lens built across 8+ years. IIT BHU pharmaceutical engineers at every level of the engagement.
60+ specialists. One process. Every deliverable in-house. Gurgaon, since 2018.
Strategy Lead · IIT BHU + IIM Bangalore
Leads scientific strategy and quality governance. Sets the standard for scientific rigour across every engagement.
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Operations Lead · IIT BHU (B.Tech + M.Tech)
Owns the AI-powered delivery system — the multi-tenant operations layer that runs every pharma engagement on time and on spec.
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Business & Growth Lead · IIT BHU + IIM Rohtak
Pharma engineer who owns business growth and the commercial lens connecting science to prescription outcomes.
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IIT BHU · M.Pharm
Aditi leads every pharma engagement end to end — from scoping the scientific writing architecture to governing quality across delivery. Her M.Pharm from IIT BHU means she doesn't need the science explained to her. "She explains it to everyone else."
A PSUR (Periodic Safety Update Report) is submitted for marketed products under ICH E2C(R2) — it integrates worldwide marketing authorisation status, patient exposure, literature, ongoing studies, signal evaluation, and benefit-risk assessment over a defined data lock point interval. A DSUR (Development Safety Update Report) covers investigational medicinal products under ICH E2F — an annual report on the safety of drugs in clinical development. A PBRER (Periodic Benefit-Risk Evaluation Report) is the EMA's implementation of ICH E2C(R2) — structurally similar to a PSUR but with explicit benefit-risk integration sections required by EMA. ICG writes all three.
Scoping call within 24 hours of first contact. Literature search protocol within 48 hours of scoping call. Full engagement start within 5 business days. For urgent deadlines (less than 4 weeks to submission), WhatsApp Aditi Tripathi directly at +91 81302 26224 — urgent engagements are assessed for feasibility in the scoping call and fast-tracked where possible.
ICG handles the full literature search as part of the PSUR engagement — from search protocol design through PubMed query execution, de-duplication, evidence quality scoring, and audit-ready search log production. All search methodology is documented and signed off by the client before the search runs. If your team has an existing search protocol, ICG can execute against it or recommend improvements.
Yes. ICG writes PSURs compliant with ICH E2C(R2) as adopted by CDSCO for Indian marketing authorisations, EMA EURD list requirements for EU submissions, and FDA requirements for US reporting. For products with multi-market authorisations, ICG produces a core PSUR with market-specific addenda as required.
Minimum requirements: cumulative and interval safety database case line listings, worldwide marketing authorisation status, patient exposure data (sales volumes or patient-years estimate), previous PSUR if available, and reference safety information (Company Core Safety Information or approved SmPC). The scoping call confirms exactly what is available and what ICG will generate during the engagement.
Start with a scoped pilot — one section of your PSUR, full ICG process, complete audit trail. You see exactly how the report is built before committing to the full engagement.
Our team member will reach out within one business day. In the meantime — WhatsApp Rohit directly for the fastest reply.
💬 Message Rohit on WhatsApp
For pharma / life sciences — medical writing, scientific communications, regulatory support — I reply personally.
Message Rohit on WhatsAppOr call: +91 81302 26224