Solutions by stage
Development Submission/Authorization Post-marketing
Specialized fields
Biotech Medical Cannabis Brexit Project Management
Pharmacovigilance Overview
Clinical Safety Overview
Quality Management Overview
QPPV
Safety Data Management
Signal and Benefit Risk
Medical Writing
Pharmacovigilance IT Systems
Clinical Safety
Local Pharmacovigilance
Regulatory Intelligence
Solutions by stage
Development Submission/Authorization Post-marketing
Specialized fields
Biotech Medical Cannabis Brexit Project Management
Regulatory Affairs Overview
Regulatory Consulting
Regulatory Applications and Submissions
Regulatory Operations
Solutions by stage
Development Submission/Authorization Post-marketing
Specialized fields
Biotech Medical Cannabis Brexit Project Management
Quality Assurance and Auditing Overview
GVP Auditing
Regulatory Inspections
QA Management
QA Consulting
SDEA/PVA Management
Solutions by stage
Development Submission/Authorization Post-marketing
Specialized fields
Biotech Medical Cannabis Brexit Project Management
Main menu
QPPV
Safety Data Management
Signal and Benefit Risk
Medical Writing
Pharmacovigilance IT Systems
Clinical Safety
Local Pharmacovigilance
Regulatory Intelligence
Pharmacovigilance Overview Clinical Safety Overview Quality Management Overview
Main menu
Regulatory Consulting
Regulatory Applications and Submissions
Regulatory Operations
Regulatory Affairs Overview
Main menu
GVP Auditing
Regulatory Inspections
QA Management
QA Consulting
SDEA/PVA Management
Quality Assurance and Auditing Overview
Case Study PV

Case Studies.

Our company's success stories.

Selected case studies.

All Auditing & QA Pharmacovigilance Regulatory Affairs
Regulatory Affairs
Medical writing, Non-clinical modules, Gap analysis
A Medical Writing project covering nine non-clinical modules (m2.4) for two products in different pharmaceutical forms and dosages.
Pharmacovigilance
Clinical Safety, Clinical Trials
Supporting an American pharmaceutical company with safety and efficacy in clinical trials
Auditing & QA
Project management, Gap analysis, Documentation
A proactive approach to passing a PV audit. Th2
Regulatory Affairs
Automation, Process improvement
Providing transparency on request status, time spent on each request, speeding processes and reducing error.
Regulatory Affairs
Gap analysis, Submission strategy, Local liaison
Auditing & QA
Audit support, Gap analysis
Leveraging prior experience to fast track preparations thumb.
Regulatory Affairs
Brexit, Gap analysis
Moving fast on a MHRA application before Brexit deadline TH
Regulatory Affairs
Gap analysis, MAA, National registration
Swift support to meet deadline cover
1 2 3

What our clients say about us.

ICON plc

I would like to remark on your excellent collaboration with ICON; transparent communication style; timely escalation, responsiveness to the ICON team at all times. This project has encountered many challenges and you have been resilient and committed to the project throughout. Your professional conduct has been exemplary and I am truly grateful.

Barry Rice
Project Managment Director, ICON plc, Ireland
View all