Full-Spectrum Life Science
Consulting Services
From your first regulatory submission to post-marketing lifecycle management, Clavanetia provides deeply integrated pharmacovigilance, regulatory affairs, and medical writing services across the entire EMEA region.
Pharmacovigilance Services
Our pharmacovigilance team delivers comprehensive safety surveillance solutions that protect patients, ensure regulatory compliance, and safeguard your marketing authorisations across all EMEA jurisdictions.
We cover the full PV spectrum — from individual case safety report processing to complex signal management and benefit-risk evaluation — under GVP-compliant processes and robust SOPs.
- ICSR intake, assessment, coding and submission to EudraVigilance, MHRA Yellow Card and national databases
- Proactive and reactive signal detection using MedDRA-coded data and disproportionality analysis
- PSUR, PBRER and DSUR authorship and coordination
- Risk Management Plan (RMP) development and maintenance
- Literature monitoring and surveillance programme management
- PV system setup, gap analysis and inspection readiness
Regulatory Affairs
Navigating the EMEA regulatory landscape requires deep procedural knowledge, strategic thinking, and established agency relationships. Our regulatory affairs team brings all three.
Whether you are seeking your first EMA centralised approval or managing a complex lifecycle variation programme across multiple countries, we design and execute strategies that get results efficiently.
- Marketing Authorisation Applications via centralised, decentralised, mutual recognition and national procedures
- Regulatory strategy development and competitive landscape analysis
- Type IA, IB and II variation applications including complex changes
- Renewal dossiers and sunset clause management
- EMA scientific advice, PRIME and ATMP designation
- UK MHRA submissions and Great Britain strategy
- Country-specific submissions for Middle East and African markets
Medical Writing
Precise, compelling scientific documentation is critical to regulatory success. Our medical writers combine deep therapeutic knowledge with mastery of ICH, GVP and EMEA submission standards.
From complex clinical study reports to patient-facing materials, we produce documents that are scientifically rigorous, strategically aligned and submission-ready on time.
- Clinical Study Reports (CSR) to ICH E3 standard — full and abbreviated formats
- Investigator Brochures (IB) and IB updates for ongoing clinical programmes
- CTD modules (2.5, 2.7, 5.3) for both small molecules and biologics
- DSURs, Annual Safety Reports and aggregate safety documents
- Regulatory responses, briefing documents and position papers
- Manuscripts, conference abstracts and scientific publications
- Patient Information Leaflets (PILs) and Instructions for Use
⚠️ EU Legal Requirement: Every company holding an EU marketing authorisation must appoint a Qualified Person for Pharmacovigilance (QPPV) residing within the EU/EEA. Clavanetia provides this as a fully managed service.
QPPV & Local PV Support
Every company with a marketing authorisation in the EU/EEA is legally required to appoint a Qualified Person for Pharmacovigilance residing in the EU. Clavanetia provides experienced, fully qualified QPPVs and local PV representatives as a managed service.
Our QPPV service gives you immediate compliance without needing to establish a European entity or hire a full-time employee — saving time, cost and complexity.
- Named, EMA-registered QPPV for your marketing authorisation
- Backup QPPV to ensure uninterrupted coverage and business continuity
- Local PV Representatives for specific EMEA markets
- Pharmacovigilance System Master File (PSMF) authorship and maintenance
- PV system oversight, QMS management and regulatory authority interactions
- Inspection management and regulatory agency liaison on PV matters
Why Partner with Clavanetia?
In a crowded consultancy market, the difference lies in depth of expertise, quality of delivery, and genuine commitment to your success. Here is what sets Clavanetia apart.
Pure Specialist Focus
We do not try to be everything to everyone. Our exclusive focus on pharmacovigilance, regulatory affairs and medical writing means you get unmatched depth of expertise — not generalist advice from a multi-service firm.
Genuine EMEA Reach
With offices in Cairo and London and an established network across 50+ EMEA markets, we provide truly localised expertise — from EMA centralised procedures to GCC country submissions and African national authorities.
Boutique Agility
We move at the speed your business demands. No bureaucracy, no account management layers — just direct access to senior experts who understand your product and respond with the urgency the situation requires.
Inspection-Ready Quality
Every deliverable we produce is built to withstand regulatory scrutiny. Our SOPs, QMS and documentation standards are designed from the ground up to meet EMA, MHRA and national authority inspection requirements — protecting you when it matters most.
Long-Term Partnership Mindset
We measure our success by yours. Rather than closing transactions, we build lasting relationships — embedding ourselves in your strategy, anticipating regulatory challenges before they arise, and growing with you across your entire EMEA portfolio lifecycle.