RedLine Pharmacovigilance
Red Line Pharmacovigilance is a company that provides outsourcing support for pharmacovigilance activities within the pharmaceutical industry. They support both human medicinal products and medical devices, ensuring compliance with EU and UK regulatory requirements. Their services include medical information handling, pharmacovigilance, literature monitoring, and training, aiming to promote the safe and effective use of pharmaceutical products.
Industries
Nr. of Employees
small (1-50)
RedLine Pharmacovigilance
Milton Keynes, Milton Keynes, United Kingdom, Europe
Products
Company brochure (PDF)
Overview brochure describing company services and contact information (PDF).
Company brochure (PDF)
Overview brochure describing company services and contact information (PDF).
Services
Outsourced PV services including adverse event intake, case processing, assessment and reporting to meet regulatory obligations for medicines and medical devices.
Provision of a qualified pharmacovigilance person and governance oversight to ensure ongoing compliance with EU/UK PV legislation and Good Pharmacovigilance Practice.
Management and submission of electronic adverse event reports to regional regulatory reporting systems to satisfy reporting timelines and formats.
Response handling for medical and safety enquiries to support safe and effective product use.
Ongoing review of published articles and case reports to detect safety signals and inform safety assessments.
Provision of pharmacovigilance training courses delivered online or in-person to develop staff competency in PV processes and regulatory requirements.
Outsourced PV services including adverse event intake, case processing, assessment and reporting to meet regulatory obligations for medicines and medical devices.
Provision of a qualified pharmacovigilance person and governance oversight to ensure ongoing compliance with EU/UK PV legislation and Good Pharmacovigilance Practice.
Management and submission of electronic adverse event reports to regional regulatory reporting systems to satisfy reporting timelines and formats.
Response handling for medical and safety enquiries to support safe and effective product use.
Ongoing review of published articles and case reports to detect safety signals and inform safety assessments.
Provision of pharmacovigilance training courses delivered online or in-person to develop staff competency in PV processes and regulatory requirements.
Expertise Areas
- Pharmacovigilance outsourcing
- QPPV services and pharmacovigilance governance
- Regulatory reporting for EU and UK
- Medical information services
Key Technologies
- Electronic adverse-event reporting systems (regulatory submission)
- Literature surveillance and screening workflows
- Medical information enquiry management systems
- Online and in-person training delivery platforms