Pharmacovigilance and Safety Writing Services
Drug safety reporting is continuous, from a product's first trial through its entire market life, and each report has to evaluate benefit and risk clearly enough to satisfy global authorities. EvySaif's pharmacovigilance and safety writing services produce submission-ready aggregate safety reports and narratives, aligned to ICH guidance and the expectations of the FDA, EMA, CDSCO, and Middle East regulators.
Aggregate safety reports across the product lifecycle
Each report has its own guideline and its own moment in the product lifecycle. We prepare each to its correct guideline, integrating line listings, summary tabulations, and signal evaluation into a clear scientific argument rather than a data dump.
During clinical development
A Development Safety Update Report (DSUR) gives a comprehensive, critical analysis of the benefit-risk balance for an investigational product, prepared in line with ICH E2F.
After approval
The Periodic Benefit-Risk Evaluation Report (PBRER), also known as the Periodic Safety Update Report (PSUR), provides the periodic benefit-risk evaluation regulators require, structured to ICH E2C(R2). The Periodic Adverse Drug Experience Report (PADER) serves the equivalent need for FDA submissions.
Build the argument, not the data dump
Line listings, summary tabulations, and signal evaluation are integrated into a clear scientific argument, with benefit-risk interpretation handled by someone who reads the clinical picture rather than only the tabulations.
Work to your lock points
We build our reporting workflow around your data lock points and submission deadlines, so milestones are predictable, and we keep the scientific narrative consistent with your CSRs and regulatory dossier.
Who it is for: Marketing Authorisation Holders, sponsors with active trials, generic and biosimilar companies, and pharmacovigilance service providers needing specialist or overflow aggregate-report authoring. We support both the development phase and the post-marketing phase.
What we prepare
DSURDevelopment Safety Update Reports (ICH E2F) for ongoing clinical programmes.
PSUR and PBRERPeriodic Benefit-Risk Evaluation Reports (ICH E2C(R2)) for marketed products.
PADERPeriodic Adverse Drug Experience Reports for the FDA.
Risk Management PlansSafety specification, pharmacovigilance plan, and risk-minimisation measures.
Patient safety narrativesFor serious adverse events, SUSARs, and deaths.
ACO and local reportsAddendum to Clinical Overview and country-specific safety reports.
How EvySaif helps
We prepare each report to its correct guideline and integrate line listings, summary tabulations, and signal evaluation into a clear scientific argument. We build the workflow around your data lock points and submission deadlines, and keep the narrative consistent with your CSRs and regulatory dossier.
Why EvySaif
EvySaif is one of the best research and medical writing consultancies in India, and it shows in the quality of every deliverable. Safety writing is where clinical judgement matters most, and ours is clinician-led. Benefit-risk interpretation and signal evaluation are handled by someone who reads the clinical picture, not just the tabulations. EvySaif maintains portfolio DSUR and PBRER documents that demonstrate this standard and are available for review.
Frequently asked questions
A DSUR covers an investigational product during clinical development (ICH E2F). A PSUR or PBRER covers a marketed product's periodic benefit-risk evaluation after approval (ICH E2C(R2)). They share a purpose but apply at different lifecycle stages.
Yes, for serious adverse events, SUSARs, and deaths, either standalone or as part of an aggregate report or CSR.
Yes. We author RMPs covering the safety specification, pharmacovigilance plan, and risk-minimisation activities.
FDA, EMA, CDSCO, and Middle East regulators, with reports structured to the relevant ICH guidance and any region-specific annex requirements.
Have a different question?
Tell us about your product, market, and timeline, and a clinician on our team will reply with specifics rather than a sales script.
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