Safety Writing & Aggregate Reports Vendors
Compare safety writers for aggregate reports such as PSURs, PBRERs, DSURs and PADERs, plus safety narratives and issue reports.
Writing CTD modules or briefing packages? See Regulatory Writing & Dossier Content.
Related workflows
CRO / Research Services Provider · +1 more type
“We also prepare Periodic Safety Update Reports (PSURs) and support risk management plan development and implementation as required by COFEPRIS post-approval conditions…”Source: althian.com
Also offers: Full-Service Clinical Trial Execution (CRO Services), Marketing Authorization & Lifecycle Submission Support, +3 more
CRO / Research Services Provider · +2 more types
Products: InStat, CoAuthor
“Our highly qualified Pharmacovigilance experts produce periodic aggregate reports in both the ICH formats (such as DSURs, PSURs, PBRERs) and non-ICH formats (such as U.S. PADERs…”Source: veristat.com
Also offers: Biostatistics & Statistical Programming, Full-Service Clinical Trial Execution (CRO Services), +3 more
Service Provider · +2 more types
Products: D.AI.M.I.
“PLG supports our clients through the following types of reports covering large regulatory landscape (EU, UK, USA, Australia, Canada and ROW countries): DSURs- PBRERs PADERs”Source: plglifesciences.com
Also offers: Regulatory Development Strategy & Agency Interactions, End-to-End Pharmacovigilance Outsourcing, +6 more
CRO / Research Services Provider · +5 more types
“Integrated summaries of safety/efficacy Annual and periodic safety reports”Source: frontagelab.com
Also offers: Bioanalysis & Biomarker Assay Services, Integrated CDMO/CMO Services, +3 more
Consulting / Advisory Firm · +2 more types
“…Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs) and Development Safety Update Reports (DSURs) Risk Management Plans (RMPs)…”Source: voisinconsulting.com
Also offers: Regulatory Development Strategy & Agency Interactions, Market Access Strategy & Launch Planning, +3 more
CRO / Research Services Provider · +2 more types
Products: ClinQuick
“IND annual reports (DSUR) and maintenance”Source: celerion.com
Also offers: First-in-Human (Phase I) Clinical Pharmacology Support, Clinical Trial Bioanalytical & Biomarker Testing, +2 more
Compare listed vendors
What this covers: Authoring or production of recurring and cumulative safety reports and related safety narratives or analyses, including PSUR, PBRER, DSUR, PADER, annual safety reports, and issue-related reports.
| Vendor | Delivery model | Also offers | In their words |
|---|---|---|---|
| Althian Clinical Research | CRO / Research Services Provider | Benefit-Risk Assessment & Safety Evaluation, Risk Management Plans & REMS | “We also prepare Periodic Safety Update Reports (PSURs) and support risk management plan development and implementation as required by COFEPRIS post-approval…”althian.com · reviewed Oct 24, 2026 |
| Celerion | CRO / Research Services Provider | — | “IND annual reports (DSUR) and maintenance”celerion.com · reviewed Oct 20, 2026 |
| Frontage Laboratories | CRO / Research Services Provider | — | “Integrated summaries of safety/efficacy Annual and periodic safety reports”frontagelab.com · reviewed Oct 14, 2026 |
| ProductLife Group | Service Provider | Benefit-Risk Assessment & Safety Evaluation, Risk Management Plans & REMS | “PLG supports our clients through the following types of reports covering large regulatory landscape (EU, UK, USA, Australia, Canada and ROW countries): DSURs-…”plglifesciences.com · reviewed Oct 26, 2026 |
| Veristat | CRO / Research Services Provider | Benefit-Risk Assessment & Safety Evaluation, Risk Management Plans & REMS | “Our highly qualified Pharmacovigilance experts produce periodic aggregate reports in both the ICH formats (such as DSURs, PSURs, PBRERs) and non-ICH formats…”veristat.com · reviewed Oct 21, 2026 |
| Voisin Consulting Life Sciences | Consulting / Advisory Firm | Benefit-Risk Assessment & Safety Evaluation, Risk Management Plans & REMS | “We offer comprehensive clinical safety solutions including case processing from intake through regulatory submission, aggregate safety reports, contribution to…”voisinconsulting.com · reviewed Oct 24, 2026 |