VI.REL Pharma
VI.REL Pharma offers comprehensive solutions for every phase of the lifecycle of pharmaceutical products, providing specialized consultancy services that support products from development to marketing, including Pharmacovigilance, Regulatory Intelligence, and Medical Writing. Celebrating 35 years of activity, the company emphasizes commitment, passion, and trust built over time, aiming to continue innovating and supporting clients worldwide.
Industries
Nr. of Employees
small (1-50)
Services
End-to-end pharmacovigilance support including QPPV/Deputy QPPV coverage, local PV contact, PSMF development, ICSR processing, signal detection, PSUR/RMP preparation, safety database management, audits and inspection support.
Strategic regulatory planning, pre- and post-authorization support, agency interactions, orphan designation assistance, and management of marketing authorisation dossiers and renewals.
Preparation and review of CTD/eCTD modules, Clinical and Non‑clinical overviews, DSURs, CSRs, addenda and scientific publications, plus review of promotional materials and APIs.
Safety oversight for clinical studies including SAE/SUSAR management, DSUR and DSUR preparation, RSI drafting, SMP and CSR support, CTA assistance and IMP benefit-risk assessments.
In-person and online courses for individuals and companies on pharmacovigilance, regulatory affairs, medical writing and GCP-compliant clinical trial conduct.
End-to-end pharmacovigilance support including QPPV/Deputy QPPV coverage, local PV contact, PSMF development, ICSR processing, signal detection, PSUR/RMP preparation, safety database management, audits and inspection support.
Strategic regulatory planning, pre- and post-authorization support, agency interactions, orphan designation assistance, and management of marketing authorisation dossiers and renewals.
Preparation and review of CTD/eCTD modules, Clinical and Non‑clinical overviews, DSURs, CSRs, addenda and scientific publications, plus review of promotional materials and APIs.
Safety oversight for clinical studies including SAE/SUSAR management, DSUR and DSUR preparation, RSI drafting, SMP and CSR support, CTA assistance and IMP benefit-risk assessments.
In-person and online courses for individuals and companies on pharmacovigilance, regulatory affairs, medical writing and GCP-compliant clinical trial conduct.
Expertise Areas
- Pharmacovigilance system implementation and operations
- Regulatory affairs and lifecycle management
- Regulatory dossier compilation and eCTD submissions
- Clinical trial safety and pharmacovigilance
Key Technologies
- Validated electronic safety databases for ICSRs
- EudraVigilance and regulatory safety reporting platforms
- eCTD electronic dossier management
- MedDRA coding and standardized medical dictionaries
News & Updates
This year, VI.REL Pharma celebrates 35 years of activity, reflecting commitment, passion, and trust built over time. The milestone is marked by gratitude to clients, partners, and collaborators, with a future still to be written together.
This year, VI.REL Pharma celebrates 35 years of activity, reflecting commitment, passion, and trust built over time. The milestone is marked by gratitude to clients, partners, and collaborators, with a future still to be written together.