QPPV / Pharmacovigilance Support

Why It Matters

Pharmacovigilance is a regulatory obligation and a patient safety priority. Every Marketing Authorization Holder in the EU/UK must appoint a Qualified Person for Pharmacovigilance (QPPV) to oversee drug safety and risk management.

Our Expertise

We provide comprehensive pharmacovigilance services, ensuring your products comply with EU GVP (Good Pharmacovigilance Practices) and global regulations.

Our Services Include

QPPV & Deputy QPPV Services – Experienced professionals based in the EU/UK.
Pharmacovigilance System Master File (PSMF) – Creation, maintenance, and compliance monitoring.
Case Management & Safety Reporting – Collection, assessment, and submission of Individual Case Safety Reports (ICSRs).
Signal Detection & Risk Management – Ongoing monitoring, analysis, and corrective action planning.
Regulatory Compliance – Inspection readiness and 24/7 QPPV availability.

Our Global Solutions

Product Selection & Development Strategy

A strong product selection and development strategy ensures that your product is not only technically feasible, but also meets unmet market needs, regulatory requirements, and commercial viability.

eCTD Dossier Preparation & Global Submissions

The electronic Common Technical Document (eCTD) is the standard format for submitting regulatory dossiers across global agencies.

Regulatory Strategy, Gap Analysis & Market Access Support

A strong regulatory strategy ensures your product development aligns with global requirements from day one. Gap analysis helps identify missing or weak areas early, saving time, cost, and reducing approval risks.

MA Holding (EU/UK/US)

Entering regulated markets like the EU, UK, and US requires a local Marketing Authorization (MA) holder to ensure compliance with complex regulations. Having a trusted MA holder allows your products to reach patients

Batch Release, Batch Testing & Warehousing Support

Ensuring the quality, safety, and timely availability of pharmaceutical and healthcare products is critical for regulatory compliance and patient safety. Proper batch testing, release procedures, and secure warehousing

BE/Biowaiver Strategy & Clinical/Non-Clinical Modules

Bioequivalence (BE) studies and Biowaiver strategies are critical for generics and certain formulations to gain approval without full-scale clinical trials.

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