Regulatory and Project Management Services

Dossier review / Gap analysis
Development of regulatory strategy
Liaison with Regulatory Authorities
Mock-ups and braille verification
Readability user testing
Quality overall summaries
Clinical and Non-clinical Overviews
Management of research and development projects
European marketing authorisation application submissions
Preparation and submission of responses to Authorities
Variation preparation and submissions
Maintenance of Product Information, including preparation and submission of updates (safety variations)
MA renewals, transfers and withdrawals
Line extensions
PSUR submissions
Conversion from NeeS format to CTD and eCTD

Regulatory and Project Management Services

Dossier review / Gap analysis
Development of regulatory strategy
Liaison with Regulatory Authorities
Mock-ups and braille verification
Readability user testing
Quality overall summaries
Clinical and Non-clinical Overviews
Management of research and development projects
European marketing authorisation application submissions
Preparation and submission of responses to Authorities
Variation preparation and submissions
Maintenance of Product Information, including preparation and submission of updates (safety variations)
MA renewals, transfers and withdrawals
Line extensions
PSUR submissions
Conversion from NeeS format to CTD and eCTD

Pharmacovigilance

Qualified Person responsible for Pharmacovigilance (QPPV) / Deputy QPPV services with 24-hour cover
Safety Physician Services
Safety Data Exchange Agreements (SDEAs)
Risk Management Plans (RMPs)
Creation and Maintenance of Pharmacovigilance System Master Files (PSMFs)
Periodic Safety Update Reports (PSURs)
Signal Detection and Management – including the use of EVDAS (EudraVigilance Data Analysis System)
Electronic PSUR Portal Registration
ADR/Individual Case Safety Report (ICSR) Processing
Provision of fully validated pharmacovigilance safety database
Expedited Reporting to Authorities
EudraVigilance registration and maintenance
Extended EudraVigilance Product Report Message (XEVMPD) product registration and Maintenance
Provision of specific company Standard Operating Procedure (SOP)
Weekly Literature Monitoring
Review of Medical Literature Monitoring (MLM) from EMA
Creation of comprehensive pharmacovigilance system
Improvement of existing pharmacovigilance system
Creation of pharmacovigilance compliance metrics
Creation of Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL)
Pharmacovigilance audit and inspection readiness
Development of pharmacovigilance CAPA management plan following inspection or audit findings
Pharmacovigilance compliance and training services

GxP Compliance Services

MIA Services
Contract QC testing and batch release
GMP and GDP compliance/audits
Assessment technical transfer
Start-up of Pharma companies to enter Europe
Preparation of supply and technical agreements

GxP Compliance Services

MIA Services

Contract QC testing and batch release

GMP and GDP compliance/audits

Assessment technical transfer

Start-up of Pharma companies to enter Europe

Preparation of supply and technical agreements

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