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
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), with the Periodic Adverse Drug Experience Report (PADER) serving the equivalent need for FDA submissions. 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.
- DSUR: Development Safety Update Reports (ICH E2F) for ongoing clinical programmes
- PSUR and PBRER: Periodic Benefit-Risk Evaluation Reports (ICH E2C(R2)) for marketed products
- PADER: Periodic Adverse Drug Experience Reports for FDA
- Risk Management Plans (RMPs): safety specification, pharmacovigilance plan and risk-minimisation measures
- Patient safety narratives for serious adverse events, SUSARs and deaths
- Addendum to Clinical Overview (ACO) and local or country-specific safety reports
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.
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. 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. EvySaif maintains portfolio DSUR and PBRER documents that demonstrate this standard and are available for review.
- Frequently asked questions
What is the difference between a DSUR and a PSUR or PBRER?
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.
Do you write patient safety narratives?
Yes, for serious adverse events, SUSARs and deaths, either standalone or as part of an aggregate report or CSR.
Can you prepare a Risk Management Plan?
Yes. We author RMPs covering the safety specification, pharmacovigilance plan and risk-minimisation activities.
Which authorities do you write for?
FDA, EMA, CDSCO and Middle East regulators, with reports structured to the relevant ICH guidance and any region-specific annex requirements.