Our Services

End-to-End Regulatory Compliance Support

PVQA Auditing & Inspection Readiness

Comprehensive audit management and inspection preparation services

Affiliate, distributor, vendor, and CRO audits
Routine and risk-based audit programs
End-to-end audit management (planning, execution, reporting, CAPA)
Inspection readiness and mock inspections
Support during health authority inspections

PV Quality Management Systems (QMS)

Design, implement, and maintain robust PV quality frameworks

Design and implementation of PV QMS frameworks
SOP authoring, review, and localization
Change management, deviations, and CAPA systems
Continuous improvement and effectiveness checks
Alignment with GVP Modules and ISO principles

Pharmacovigilance Systems & Operations

Establish and maintain PV systems aligned with GVP requirements

Establishment and maintenance of PV systems aligned with GVP
End-to-end PSMF creation, governance, and maintenance
Safety data reconciliation (Medical Information, Quality, Partners)
Signal management and safety oversight
Support for ICSRs, PSURs, PBRERs, RMPs, and RMMs

Regional QPPV/LQPPV & Oversight

Qualified person and local oversight across MEA regions

Regional QPPV and Deputy QPPV services (MEA)
LQPPV support and mentoring
Oversight of PV agreements (SDEAs), partner compliance, outsourced PV
Health authority interactions and responses

Safety Data Exchange Agreements (SDEA)

Comprehensive SDEA lifecycle management

Drafting, review, and negotiation of SDEAs
Alignment with global PV systems and local regulatory requirements
Oversight of partner obligations
Ongoing SDEA compliance monitoring

Regulatory Affairs & Lifecycle Management

Full regulatory lifecycle support from registration to renewal

Pharmaceutical site registrations
Product lifecycle management (variations, renewals, labeling updates)
PSUR and RMP submission oversight
M&A and MAH transfer due diligence
Risk identification to prevent regulatory delays

Training & Capability Building

Build organizational competency in pharmacovigilance

GVP and regional regulatory training
PV audit and inspection readiness workshops
SOP and process-specific training
Training for employees, distributors, and third parties
Mentoring of junior auditors and PV professionals

Regulatory Intelligence

Stay ahead of evolving global and local regulatory requirements

Continuous monitoring of global and local regulations
Development of regulatory intelligence tools
Impact assessments on PV systems and agreements

Business Development & Due Diligence

PV and regulatory support for strategic business decisions

PV and regulatory due diligence (licensing, M&A, partnerships)
Vendor and distributor qualification
Compliance risk assessments
Strategic input to BD teams during deal evaluations

Ready to strengthen your PV compliance?

Talk to our team about how we can support your pharmacovigilance and regulatory needs.

Contact Us Today