Do you have pharmacovigilance-certified professionals on staff?

Yes, our team includes pharmacovigilance specialists with life sciences degrees, formal PV training, and MedDRA/WHODrug certification. Many team members have direct experience with pharmaceutical companies, CROs, and regulatory agencies. All team members complete comprehensive training on ICH guidelines, GVP modules, and client SOPs.

Can you handle expedited reporting for serious adverse events?

Absolutely. We provide 24-hour to 7-day expedited reporting services for serious, unexpected suspected adverse reactions (SUSARs) and meet all FDA 15-day/7-day reporting requirements. We follow client SOPs for expectedness assessment, causality determination, and regulatory submission timelines.

Is your pharmacovigilance support scalable to meet changing business needs?

Yes, our services are fully scalable, allowing pharmaceutical and biotech companies to expand or adjust pharmacovigilance operations based on product pipelines and regulatory demands.

Can you support aggregate safety reporting (PSURs/PBRERs)?

Yes, we provide comprehensive support for Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and annual safety reports. Our services include data compilation, safety table generation, narrative writing, and regulatory formatting.

Do you have experience with global regulatory requirements?

Yes, our team has experience with FDA (21 CFR 312.32), EMA (GVP modules), PMDA, Health Canada, and other global regulatory authorities. We understand regional differences in reporting timelines, format requirements, and regulatory expectations for pharmacovigilance activities.

How do you ensure data quality and compliance?

We implement multi-tier quality control with independent review of all ICSRs, coding validation, narrative review, and regulatory compliance checks. Our quality management system includes SOPs, training records, audit trails, and performance metrics aligned with GVP and ICH-GCP requirements.

Do you support both clinical trial and post-marketing safety activities?

Yes, we provide comprehensive pharmacovigilance support across the full product lifecycle, covering clinical development, post-approval, and lifecycle management.

Will you offer case follow-up and medical review support?

Yes, we conduct timely case follow-ups, medical assessments, and narrative reviews to ensure completeness, clinical relevance, and regulatory compliance.

Can you integrate with our existing pharmacovigilance systems and workflows?

Yes, our teams seamlessly align with your existing systems, SOPs, and workflows to ensure smooth collaboration and minimal operational disruption.

How do you handle safety signal detection and evaluation?

We support structured signal detection, validation, and evaluation processes using clinical judgment, data trends, and regulatory guidance.

Pharma Case Review & Pharmacovigilance Support

Pharma & Drug Safety

Pharmaceutical Case Review & Pharmacovigilance

Looking to speed up pharmacovigilance procedures without slowing your business operations? LezDo TechMed can offer the best solution with expert pharmacovigilance services, ICSR processing, MedDRA coding, and compliant safety reporting.With a full spectrum of pharmaceutical case review services, we support your business right from clinical trials to post-marketing surveillance.

Request PV Support

Download Samples

150,000+

ICSRs Processed Annually

50+

Pharmaceutical Products Supported

99.5%

Accuracy Rate

24-48 hrs

Expedited Report Turnaround

Pharmacovigilance Operational Challenges

Pharmaceutical companies operate in a high-risk environment of rigorous regulatory standards, that impact their efficiency, timelines, and overall business performance.

Pharmacovigilance & Safety Reporting

Monitoring and preparing reports on adverse drug reactions, & signal detection as per the guidelines of the global regulatory authorities.

Post-Marketing Surveillance

Analyzing the records on post-marketing studies, spontaneous reports, and registries to identify safety signals and product effectiveness patterns.

Medical Information & Inquiry Response

Providing timely, accurate inquiry responses to healthcare & regulatory authorities about drug indications, contraindications, adverse events, and off-label use.

Regulatory Compliance Timelines

Meeting the FDA, EMA, and global regulatory deadlines for periodic safety reports (PSURs/PBRERs), ICSRs, and risk management plans (RMPs).

How We Support Your Pharmacovigilance Operations

From development to post-marketing, we provide end-to-end pharma case review services for seamless pharmacovigilance operations.

Case Processing & MedDRA Coding

Comprehensive individual case safety report (ICSR) processing including data entry, medical coding (MedDRA/WHODrug), narrative writing, and causality assessment for regulatory submission.

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MedDRA LLT/PT coding

WHODrug B/C coding

ICSR narrative preparation

Literature Review & Signal Detection

Systematic monitoring of medical literature, regulatory databases, and spontaneous reports to identify emerging safety signals and support aggregate reporting requirements.

PubMed/Embase monitoring

Signal detection analysis

DSUR/PSUR/PBRER support

Medical Information Services

Expert response to healthcare professional and patient inquiries regarding product information, adverse events, drug interactions, and therapeutic use based on approved labeling.

HCP inquiry response

Standard response letters

Off-label inquiry management

Regulatory Documentation Support

Preparation and compilation of safety-related regulatory documents including RMPs, PSURs/PBRERs, DSURs, aggregate reports, and responses to health authority questions.

PSUR/PBRER compilation

RMP preparation

Safety table generation

Complete PV Coverage

Our Pharmacovigilance Service Areas

Full-spectrum drug safety services across all PV functions

Pharmacovigilance Operations

ICSR Data Entry & Coding

Adverse Event Reporting (15-day/7-day)

Follow-up Management

Duplicate Case Detection

Reconciliation Activities

Aggregate Safety Reporting

PSUR/PBRER Preparation

DSUR Compilation

Annual Safety Reports

Risk Management Plans (RMP)

Signal Detection & Evaluation

Medical Information

Healthcare Professional Inquiries

Patient/Consumer Questions

Standard Response Letters

Product Information Requests

Adverse Event Intake

Regulatory Intelligence

Literature Monitoring

Regulatory Database Searches

Label Assessment

Health Authority Correspondence

Product Complaint Handling

The Difference We Deliver

We deliver precision-driven PV case reviews that ensure patient safety across every stage of the product lifecycle.

Assistance to meet global pharmacovigilance requirements across FDA, EMA, PMDA, and other regulatory authorities

Expert support to scale safety operations during peak ICSR volumes without permanent headcount increases

Certified medical coders for MedDRA and WHODrug coding accuracy

Pharmacovigilance expertise to reduce regulatory submission timelines

Competent team with deep expertise across oncology, cardiology, CNS, immunology, and 40+ specialties

Maintain compliance with GVP, ICH-E2A/B/D/E, and 21 CFR Part 312.32 requirements

Our Pharmacovigilance Expertise

MedDRA/WHODrug Certified Coders

ICH/GVP Compliance

Global Regulatory Experience

24/7 Safety Reporting

Pharmacovigilance Success Story

Mid-Size Pharmaceutical Company

Cardiovascular Portfolio

Challenge

Pharmaceutical company with 8 marketed cardiovascular products faced overwhelming ICSR backlog during post-approval period. 2,500+ cases required processing within regulatory deadlines, and internal PV team of 4 couldn't keep pace, risking compliance violations.

Solution

We deployed dedicated pharmacovigilance team providing ICSR data entry, MedDRA/WHODrug coding, narrative preparation, and expedited reporting. Implemented quality control processes and met all 15-day and 7-day regulatory deadlines.