Pharma-Vigilance
PharmaVigilance Limited is a UK-based knowledge process outsourcing company established in 2013, specializing in Pharmacovigilance (PV) and Regulatory Affairs services. They provide cost-effective, high-quality support to pharmaceutical companies of all sizes, focusing on maintaining regulatory compliance and quality standards. Their mission is to deliver high standards of quality and excellence, with a vision to be a trendsetter in the consulting industry through innovative and consistent approaches. They offer a wide range of services including pharmacovigilance, medical writing, regulatory affairs, publishing, auditing, and training, supported by a team of experienced professionals and collaborations with ex-regulators and industry experts.
Industries
Nr. of Employees
small (1-50)
Pharma-Vigilance
Slough, Buckinghamshire, United Kingdom, Europe
Services
Outsourced authoring and review of PV deliverables including RMPs, PSMFs, PBRERs/PSURs, DSURs, SOPs, case narratives and literature-based benefit–risk assessments.
Establishment and transfer of pharmacovigilance QMS aligned with GVP Module I, including PSMF and critical SOP development.
Conducting PV audits, gap analyses, mock inspections and inspection readiness programs; preparing SPS and CAPA planning and management.
Preparation, compilation and publishing support for CTD/eCTD dossiers and other regional formats for EU, US and ROW applications, including strategy for submission routes (CP, MRP, DCP, NP, IND, NDA, BLA, ANDA).
Electronic publishing, validation and submission of regulatory dossiers and documents (e.g., MAA, IND, NDA, BLA, ANDA, DMF, variations, PBRER/PADER) using publishing tools and validators.
Support services for the EU Qualified Person for Pharmacovigilance including document review, aggregate report support and advice on safety data exchange agreements.
Outsourced authoring and review of PV deliverables including RMPs, PSMFs, PBRERs/PSURs, DSURs, SOPs, case narratives and literature-based benefit–risk assessments.
Establishment and transfer of pharmacovigilance QMS aligned with GVP Module I, including PSMF and critical SOP development.
Conducting PV audits, gap analyses, mock inspections and inspection readiness programs; preparing SPS and CAPA planning and management.
Preparation, compilation and publishing support for CTD/eCTD dossiers and other regional formats for EU, US and ROW applications, including strategy for submission routes (CP, MRP, DCP, NP, IND, NDA, BLA, ANDA).
Electronic publishing, validation and submission of regulatory dossiers and documents (e.g., MAA, IND, NDA, BLA, ANDA, DMF, variations, PBRER/PADER) using publishing tools and validators.
Support services for the EU Qualified Person for Pharmacovigilance including document review, aggregate report support and advice on safety data exchange agreements.
Expertise Areas
- Pharmacovigilance and drug safety
- Regulatory affairs and dossier preparation
- eCTD and electronic regulatory publishing
- PV quality management systems (GVP)
Key Technologies
- eCTD publishing platforms
- CTD/eCTD dossier authoring
- Structured Product Labelling (SPL)
- Aggregate safety reporting (PBRER/PSUR/DSUR)
News & Updates
Recognition for providing cost-effective, high-quality PV services and maintaining compliance with regulatory requirements.
Recognition for excellence in PV services and compliance.
Recognition for providing cost-effective, high-quality PV services and maintaining compliance with regulatory requirements.
Recognition for excellence in PV services and compliance.