Expert Pharmacovigilance
and Regulatory
Consulting
Clavanetia Consulting delivers end-to-end pharmacovigilance, regulatory affairs, and medical writing services to pharmaceutical and biotech companies operating across Europe, the Middle East, and Africa.
Explore Our ServicesFull-Spectrum Life Sciences Consulting
From signal detection and PSUR authorship to MAA submissions and medical writing, Clavanetia provides seamlessly integrated services at every stage of your product's lifecycle.
Pharmacovigilance
Comprehensive PV services ensuring patient safety and regulatory compliance across the full product lifecycle — from clinical development through post-marketing surveillance.
Regulatory Affairs
Strategic regulatory guidance for EMEA market access, submissions, lifecycle management, and agency interactions — tailored to your product and target markets.
Medical Writing
Precise, publication-ready scientific documents crafted by experienced medical writers with deep therapeutic area expertise and ICH/GVP guideline knowledge.
Safety Surveillance
Proactive benefit-risk monitoring through systematic signal management, aggregate reporting, and real-world evidence analysis to protect patients and products.
QPPV & Local PV Support
Qualified Person for Pharmacovigilance (QPPV) services and local country representation to meet EU and national competent authority requirements efficiently.
EMEA Market Access
Dedicated support for Middle East and Africa regulatory pathways, including country-specific dossier preparation and strategic market entry planning.
Your Trusted EMEA Regulatory Partner
Clavanetia Consulting was founded with a singular mission: to provide pharmaceutical and biotech companies with expert, reliable, and commercially astute regulatory and pharmacovigilance support across the EMEA region.
Our team of seasoned specialists brings decades of combined experience from regulatory agencies, global pharma companies, and CROs — delivering the depth of knowledge and agility that modern drug development demands.
We operate as a true extension of your team, aligning our strategies with your business objectives while maintaining the highest standards of scientific integrity and regulatory compliance.
Why Companies Choose Clavanetia
Unlike generalist consultancies, we concentrate exclusively on pharmacovigilance, regulatory affairs, and medical writing — giving you depth over breadth and genuine subject-matter mastery.
We combine the personal service of a boutique consultancy with the capacity and systems of a larger organisation — responding quickly and scaling resources to match your timelines.
With established networks and local expertise spanning Europe, the Middle East, and Africa, we navigate the regulatory landscape in over 50 markets on your behalf.
Our systems, processes, and documentation standards are designed to withstand EMA, MHRA, and national authority inspections — protecting you when it matters most.
We invest in understanding your pipeline, portfolio, and strategic goals — working collaboratively rather than transactionally to add long-term value to your organisation.
Our signal detection and benefit-risk assessments are underpinned by sophisticated analytics, providing actionable intelligence to support sound regulatory decisions.
Our Engagement Process
We begin with a detailed scoping call to understand your regulatory landscape, current gaps, timelines, and strategic objectives.
Our experts design a tailored regulatory or PV strategy, identifying the optimal pathway, resources, and deliverables for your product.
We deliver with precision — preparing submissions, processing safety data, authoring documents — against agreed timelines and quality standards.
Transparent reporting, regular project updates, and ongoing quality review ensure you remain in control at every stage of the engagement.
Trusted by Industry Leaders
"Clavanetia transformed our EMEA pharmacovigilance infrastructure. Their QPPV team is exceptionally knowledgeable and the quality of our PSURs has improved dramatically."
Dr. S. Hartmann VP Regulatory Affairs, European Biotech"The medical writing team delivered a flawless Clinical Study Report on an aggressive timeline. Their scientific rigour and attention to ICH guidelines is outstanding."
M. Al-Rashid Director of Clinical Operations, MENA Pharma"Their regulatory team secured our MAA approval six weeks ahead of schedule. Clavanetia's expertise in EMA procedures is genuinely second to none."
C. Okonkwo CEO, Pan-African Generics GroupBegin Your Regulatory Journey
Ready to discuss how Clavanetia Consulting can support your pharmacovigilance, regulatory affairs, or medical writing needs across EMEA? Our experts are ready to listen.
London, United Kingdom
Request a Consultation
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