Our Services
Pharmacovigilance
- UK Qualified Person for Pharmacovigilance (UK QPPV)
- UK National Contact Point
- Weekly Literature Searches
- Periodic Safety Update Reports (PSURs)
- Risk Management Plans (RMPs)
- Ongoing Signal Detection & Evaluation
- ADR Electronic Reporting
- ADR Investigation & Medical Information
- Inspection Preparation & Hosting
GMP & GDP Compliance
- Responsible Person for GDP
- RPi Responsible Person for Importation
- Two “Gold Standard” Qualified RPs
- GDP and GMP Compliance Gap Analysis
- Inspection Preparation
- Medicinal Product Supply Chain and Transportation Expertise
- Stability and Protocols and Study Management
MIA, MIA (IMP), ManA, MS 29498
- Importation to the UK from EEA & ROW
- Batch Release & QP Certification
- Human & Veterinary Medicinal Products
- Unlicensed Medicinal Products (Specials)
- Importation for Clinical Trials
Quality Management Systems
- Cloud Based Solutions
- Standard Operating Procedures Origination
- GMP, GDP, Medical Device ISO13485
- CAPA, Audits, Change Control
- Quality Review Meetings
- Key Performance Indicators
- Tried and Tested Processes Adapted For Your Needs
- QMS & SOP Management
Regulatory Affairs inc eCTD
- Human and Veterinary Medicinal Products
- New MAA & Variations & PIQU submissions
- WDA, MIA, ManA, MS Submissions
- Renewals, transfer of ownership, sunset clause
- Regulatory strategy and support
- Origination, compiling, publishing & validation eCTD
Medical Devices
- Quality Management Representative
- Responsible Person and Authorised Representative
- Medical Device Technical Files (TF)
- Vigilance
- Labelling Compliance
All Services
