Experts in Pharmacovigilance & Drug Safety Leadership
Specialized pharmacovigilance and drug safety consultant delivering strategic, science-driven safety solutions across the entire product lifecycle. I partner with pharmaceutical, biotechnology, and healthcare organizations worldwide to strengthen safety oversight, ensure global regulatory compliance, and support informed benefit–risk decision-making. My expertise helps companies maintain inspection-ready pharmacovigilance systems while protecting patient safety and advancing therapeutic innovation.
What I Do?
My Expertise in Pharmacovigilance & Drug Safety Leadership
I deliver inspection-ready pharmacovigilance solutions built on regulatory precision and operational excellence. My services ensure compliance with FDA, EMA, and ICH requirements through structured safety systems, robust documentation, and governance oversight, strengthening audit preparedness, mitigating risk, and protecting patient safety across the entire product lifecycle.
Pharmacovigilance Strategy
I provide Pharmacovigilance Strategy services that deliver a structured, scalable, and inspection-ready safety framework tailored to your development stage. I align regulatory requirements, risk management, signal oversight, and operational infrastructure to ensure compliance, market readiness, and sustainable lifecycle safety management.
Our PV Strategy Services Include:
- Safety Management Plan
- Pharmacovigilance SOPs
- Vendor Oversight
- Signal Management Framework
- Pharmacovigilance System Set-up For Entrepreneurs
Aggregate Report
Authoring and Review
I provide expert authoring and critical review of aggregate safety reports, including DSURs, PSURs/PBRERs, and other periodic submissions. I ensure accurate data analysis, regulatory compliance, medical consistency, and clear risk-benefit evaluation to support global health authority requirements and inspection readiness.
Our Aggregate Report Authoring & Review Services Include:
- DSUR
- PSUR / PBRER
- IND/ NDA Annual Reports
- PADERs
Signal Detection and Benefit–Risk Assessments
- Signal Evaluation Reports
- Safety Governance Meeting Support
- Data Analysis And Interpretation
Inspection and Regulatory Readiness
I prepare organizations for confident regulatory inspections through structured gap assessments, SOP remediation, and proactive compliance strengthening. I provide health authority response support, documentation review, and governance alignment to ensure inspection readiness, regulatory confidence, and sustained pharmacovigilance compliance across the product lifecycle.
Our Inspection & Regulatory Readiness Services Include:
- Gap Assessments
- Gap Assessments
- Inspection Readiness
- Health Authority Response Support
Core Pharmacovigilance and Regulatory Training
I deliver comprehensive pharmacovigilance and regulatory training designed to strengthen organizational competence and compliance. My programs include Operational PV Training, Risk Management & Safety Strategy Training, Aggregate Reporting Training, and Quality Systems & Compliance Training, empowering teams with practical knowledge to support inspection readiness and sustainable safety excellence.
Our Core PV & Regulatory Training Include:
- Core Pharmacovigilance and Regulatory Training
- Operationa Pharmacovigilance Training
- Risk Management and Safety Strategy Training
- Aggregate Reporting Training
- Quality Systems and Compliance Training
SERVICES - FOR MOBILE VERSION ONLY
Pharmacovigilance Strategy
I provide Pharmacovigilance Strategy services that deliver a structured, scalable, and inspection-ready safety framework tailored to your development stage. I align regulatory requirements, risk management, signal oversight, and operational infrastructure to ensure compliance, market readiness, and sustainable lifecycle safety management.
Our PV Strategy Services Include:
- Safety Management Plan
- Pharmacovigilance SOPs
- Vendor Oversight
- Signal Management Framework
- Pharmacovigilance System Set-up For Entrepreneurs
Aggregate Report Authoring and Review
I provide expert authoring and critical review of aggregate safety reports, including DSURs, PSURs/PBRERs, and other periodic submissions. I ensure accurate data analysis, regulatory compliance, medical consistency, and clear risk-benefit evaluation to support global health authority requirements and inspection readiness.
Our Aggregate Report Authoring & Review Services Include:
- DSUR
- PSUR / PBRER
- IND/ NDA Annual Reports
- PADERs
Signal Detection and Benefit–Risk Assessments
I deliver structured signal detection and comprehensive benefit–risk assessments to proactively identify, evaluate, and communicate emerging safety concerns. My services include signal evaluation reports, safety governance meeting support, and advanced data analysis and interpretation to ensure regulatory compliance, informed decision-making, and continuous patient safety oversight.
Our Signal Detection and Benefit-Risk Assessments Services Include:
- Signal Evaluation Reports
- Safety Governance Meeting Support
- Data Analysis And Interpretation
Inspection and Regulatory Readiness
I prepare organizations for confident regulatory inspections through structured gap assessments, SOP remediation, and proactive compliance strengthening. I provide health authority response support, documentation review, and governance alignment to ensure inspection readiness, regulatory confidence, and sustained pharmacovigilance compliance across the product lifecycle.
Our Inspection & Regulatory Readiness Services Include:
- Gap Assessments
- SOP Remediation
- Inspection Readiness
- Health Authority Response Support
Core Pharmacovigilance and Regulatory Training
I deliver comprehensive pharmacovigilance and regulatory training designed to strengthen organizational competence and compliance. My programs include Operational PV Training, Risk Management & Safety Strategy Training, Aggregate Reporting Training, and Quality Systems & Compliance Training, empowering teams with practical knowledge to support inspection readiness and sustainable safety excellence.
Our Core PV & Regulatory Training Include:
- Core Pharmacovigilance and Regulatory Training
- Operationa Pharmacovigilance Training
- Risk Management and Safety Strategy Training
- Aggregate Reporting Training
- Quality Systems and Compliance Training
My Case Studies
Get To Know More About Our Case Study
Explore how I have strengthened pharmacovigilance systems, enhanced regulatory compliance, and improved inspection readiness for biotech and pharmaceutical organizations. My case studies demonstrate structured safety remediation, successful audit preparation, and strategic governance implementation that reduced risk exposure and ensured Health Authority confidence across critical development milestones.
White Paper
Insights in Pharmacovigilance Compliance
Expert perspectives on regulatory trends, inspection readiness, safety governance, and risk management strategies designed to strengthen pharmacovigilance systems and support Health Authority expectations.
White Paper
Designing a Lean, Inspection-Ready Pharmacovigilance System Before First Patient In
White Paper
Inspection- ready at all times: A Practical framework for biotech
White Paper
Why Risk-Based Therapeutic-Specific Approaches are essential
White Paper
From Phase I to Commercial: Building a Scalable Pharmacovigilance system
Need urgent pharmacovigilance expertise?
coNTACT us
Whether you are preparing for a regulatory submission, responding to a Health Authority request, or strengthening your safety systems, I am ready to assist.
Quick Links
Our Services
- Pharmacovigilance Strategy
- Aggregate Report Authoring & Review
- Signal Detection and Benefit–Risk Assessments
- Inspection and Regulatory Readiness
- Core PV and Regulatory Training
Contact Info
- monica.singh.regulatory@gmail.com
- +1 (617) 775-7630
© 2025 All rights reserved to Monica Singh