Pharmacovigilance
Pharmacovigilance documentation and regulatory compliance
A pharmacovigilance system is judged by its documentation. We prepare and maintain the documents authorities and partners expect — the pharmacovigilance system master file, risk management plans, SOPs and safety data exchange agreements — and check that they reflect how the system actually works.
- Documents PSMF, RMP, PV SOPs, SDEAs, training records
- Typical inputs Organisation, processes, products and partners
- You receive Compliant, current PV documentation
Overview
About Safety Documentation & Compliance
The pharmacovigilance system master file (PSMF) describes the PV system in detail and must be kept current. Risk management plans (RMPs) describe a product’s safety profile and how risks are minimised. SOPs and agreements define who does what, and training records show that people know their responsibilities.
Inspectors compare these documents with practice. We prepare documents that are accurate and usable, and review existing documentation for gaps.
Use cases
When this service helps
Setting up a PV system
Create the core documentation from the start.
Preparing for inspection
Check that documents are current and consistent.
New licensing partners
Draft safety data exchange agreements.
New product approvals
Prepare or update risk management plans.
Scope
What the service covers
- Pharmacovigilance system master file (PSMF) preparation and maintenance
- Risk management plan (RMP) preparation and updates
- PV SOP framework and individual procedures
- Safety data exchange agreements (SDEAs) with partners
- Corrective and preventive action (CAPA) documentation
- Compliance review of PV documentation against requirements
Who does what
Documents are owned and approved by the marketing authorisation holder. Globaxa prepares and reviews them.
Does every market require a PSMF?
The PSMF is an EU requirement; several other authorities require an equivalent description of the PV system. A well-structured PSMF is often adapted for other markets.
Methodology
How we work
A defined sequence, agreed with you at the start, so you always know what happens next and what we need from you.
- Review current stateExisting documents and practices are reviewed.
- Identify gapsDifferences from requirements and from practice are listed.
- Prepare documentsNew or updated documents are drafted.
- MaintainPeriodic updates as the system changes.
Deliverables
What you receive
PSMF
Complete master file with annexes, kept current.
RMP
Product risk management plan in the required format.
SOPs and agreements
Procedures and partner agreements.
Technical basis
Guidelines we work to
- EU GVP Module IIPharmacovigilance system master file.
- EU GVP Module V and ICH E2ERisk management systems and pharmacovigilance planning.
- National requirementsLocal PV documentation requirements, including India’s PvPI guidance.
What we need from you
- Organisation chart and PV roles
- Current SOPs, agreements and training records
- Product list and partner arrangements
- Previous audit or inspection findings
Please share confidential information only after an NDA is in place — we are happy to sign one first.
Market and jurisdiction considerations
Documentation requirements differ between the EU, India and other markets. We prepare documents that satisfy the strictest relevant requirement and add local elements where needed.
FAQs
Safety Documentation & Compliance: frequently asked questions
Can you review our existing PSMF?
Yes. We compare it with current requirements and your actual practice and recommend updates.
Do you prepare RMPs for generic products?
Yes. Generic RMPs usually reflect the reference product’s safety concerns, with any product-specific additions.
How often should SOPs be reviewed?
Typically every two to three years, or sooner when processes or regulations change.
Talk to us about Safety Documentation & Compliance
Share your product, target market and timeline. We will review your requirement and propose a defined scope.
- OfficeFlat no 8-9-3/23/1, Subhash Chandra Bose Colony, Dathunagar, Kanchanbagh, Hyderabad, Telangana 500058, India
Open in Google Maps - Phone+91 81219 33381
+91 99894 74590 - Emailbd@globaxa.in
- Office hoursMonday to Friday, 10:00–19:00 IST