What are PSMF & SOPs Preparation Services?
Our services provide EMA/MHRA-compliant PSMFs, GVP-aligned SOPs, annex structuring, and version control, ensuring a robust documentation foundation for global pharmacovigilance compliance.
PSMF & SOPs Preparation for Global Compliance
Build Robust PV Documentation for Regulatory Success
At Indivirtus Healthcare Services Pvt. Ltd., our PSMF & SOPs Preparation service delivers comprehensive, regulatory-compliant Pharmacovigilance System Master Files (PSMFs) and SOPs for MAHs and PV service providers. Tailored to EMA, MHRA, and GVP standards, we ensure inspection-ready documentation with full lifecycle management.
Why is it Critical?
Compliant PSMFs and SOPs ensure regulatory inspection readiness, operational consistency, and integration with Quality Management Systems, supporting global safety and compliance.
Our Role in Your Success
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led PV documentation solutions, providing customized, compliant PSMFs and SOPs to streamline regulatory compliance.
Our Expert Documentation Approach
At Indivirtus Healthcare Services, our PSMF & SOPs Preparation services are led by certified pharmacovigilance experts specializing in global regulatory compliance. We author EMA/MHRA-compliant PSMFs and GVP-aligned SOPs, structure annexes, and implement version control for lifecycle management.
Our tailored approach integrates with your Quality Management System, delivering inspection-ready documentation that reflects your operational setup and aligns with EMA GVP Module I, MHRA, and ICH E2E standards.
PSMF & SOPs Preparation Deliverables
EMA/MHRA-Compliant PSMF Document: Comprehensive pharmacovigilance system overview.
Custom PV SOP Set (GVP-Aligned): Tailored procedures for operational consistency.
Version Control Matrix: Traceable documentation updates for compliance.
Annex Templates and Documentation Plan: Structured tools for lifecycle management.
Regulatory Compliance & Global Standards
Our PSMF & SOPs Preparation services align with stringent global pharmacovigilance standards, ensuring your documentation is inspection-ready and compliant with international markets. By adhering to industry-leading guidelines, we deliver solutions that enhance regulatory confidence.
- EMA GVP Module I: European standards for pharmacovigilance system documentation.
- MHRA GVP Requirements: UK regulations for PV system compliance.
- ICH E2E: Guidelines for pharmacovigilance planning and documentation.
- WHO Pharmacovigilance Guidelines: Global standards for safety system documentation.
Applications & Use Cases
Our PSMF & SOPs Preparation services are essential for MAHs and PV service providers establishing or maintaining compliant pharmacovigilance systems. Ideal for regulatory inspections, system setup, or process optimization, our solutions support global compliance. Key use cases include authoring PSMFs for new MAHs, updating SOPs for GVP alignment, and ensuring inspection readiness.
Why Choose Indivirtus Healthcare
Indivirtus Healthcare Services is a trusted partner for MAHs and PV service providers, delivering expert-led PSMF and SOP solutions backed by certified pharmacovigilance experts with global experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.
With a commitment to industry best practices, we empower your organization with compliant, tailored documentation, driving regulatory success and pharmacovigilance excellence.
Frequently Asked Questions
Frequently Asked Questions
What is a PSMF and why is it important?
A Pharmacovigilance System Master File (PSMF) is a regulatory document required by EMA and MHRA to describe the PV system of the MAH. It ensures transparency, compliance, and inspection readiness.
Do you provide both EU and UK compliant PSMFs?
Yes, we prepare region-specific PSMFs aligned with EMA and MHRA formats, including region-specific annexes and role definitions.
What SOPs are typically included in PV documentation?
We develop SOPs covering ICSR management, aggregate reporting, literature screening, signal detection, database validation, and PSMF maintenance among others.
How do you manage version control and updates?
We implement a structured version control matrix and change log system to track updates across SOPs and annexes, fully integrated with the client’s QMS.
Can these documents be prepared in inspection-ready format?
Absolutely. All documents are formatted and quality-reviewed to meet inspection-readiness standards for audits by EMA, MHRA, or other global regulators.
What do PSMF & SOPs Preparation services include?
Our services include EMA/MHRA-compliant PSMFs, GVP-aligned SOPs, version control matrices, and annex templates tailored for pharmacovigilance compliance.
Who benefits from PSMF & SOPs Preparation services?
MAHs and PV service providers establishing or maintaining compliant pharmacovigilance systems for regulatory inspections benefit from our tailored solutions.
How do these services ensure regulatory compliance?
Our services align with EMA GVP Module I, MHRA GVP Requirements, ICH E2E, and WHO Pharmacovigilance Guidelines, ensuring global compliance.
What deliverables are provided with the service?
Clients receive EMA/MHRA-compliant PSMFs, custom PV SOPs, version control matrices, and annex templates/documentation plans.
Can the PSMF and SOP services be customized for our needs?
Yes, our services are tailored to your organization’s operational setup, regulatory requirements, and PV needs, ensuring compliant documentation.
How do the services support inspection readiness?
We provide comprehensive, version-controlled PSMFs and SOPs integrated with your Quality Management System, ensuring readiness for regulatory inspections.