Expert-Led Medical SafetyWriting Solutions byHAROM India
Delivering high-quality, regulatory-compliant safety documents including PSURs, DSURs, PBRERs, RMPs, and more—supported by medical writing experts and smart efficiency tools.
High-Quality Medical Writing with Uncompromised Compliance
Regulatory-compliant, evidence-based writing tailored for audit-readiness and global submissions.
- Adheres to GVP Modules, ICH E2E, and local authority guidelines
- Maintains scientific clarity, consistency, and accuracy
- Includes robust citation of safety data and risk/benefit evaluations
From Aggregate Reports to Clinical Summaries – We Do It All
Full-spectrum writing solutions tailored to your drug's safety lifecycle.
Aggregate Safety Reports
PSUR, PBRER, DSUR with comprehensive safety data analysis
Risk Management Plans
EU-RMP, India-RMP with thorough risk minimization strategies
Post-Marketing Surveillance
Comprehensive reports with signal detection
Clinical Summaries
ISS, ISE, AcoRs with expert medical interpretation
Narrative Writing
SUSAR, SAEs, Clinical Trials with medical accuracy
Regulatory Submissions
Compliant documentation for global regulatory authorities
Signal Evaluation
Safety Analysis Reports with scientific rigor
Medical Information
Scientific Content Support with evidence-based approach
Whether you're a CRO, sponsor, or pharma company, we tailor content and formats as per your target submission region and authority.
Let's Work Together
Tell Us Your PV Challenges – We'll Provide the Solution.