Complete Pharmacovigilance Solutions Ltd

Complete Pharmacovigilance Solutions (CPVS) provide expert guidance and operational solutions to the bio-pharmaceutical and medical device industries. We specialize in medical and scientific activities supporting compounds through clinical development, and post-marketing obligations throughout various stages of the product life cycle. As a committed partner in drug safety and related functions, we bring meaningful insights from our extensive industry experience and our ability to provide flexible solutions has been recognized by our clients, who continue to engage and partner with us on an ongoing basis. Headquartered in the UK, with a growing team in India, we have a truly global outlook in providing the highest quality services efficiently and cost-effectively. Our service offerings include: 1. Safety case processing and medical review 2. Market Authorization submissions and responses 3. Emergent safety issue guidance 4. Aggregate Report Preparation 5. RMP/REMS preparation 6. Signal detection and evaluation 7. Literature Monitoring and Summarization 8. Safety Data Exchange Agreements 9. XEVMPD and IDMP submissions 10. PSMF and DDPS preparation 11. Database upgrades and migrations 12. Compliance Monitoring and Audit/Inspection readiness 13. GVP and GCP auditing 14. Training 15. Regulatory Intelligence 16. Medical Device Pharmacovigilance 17. Veterinary Pharmacovigilance 18. Drug Development Strategy Planning & Regulatory Input in Clinical Programs 19. Creation of Labelling for Inclusion in Original U.S. NDA and MAA 20. Designing and review of Quality Systems For enquiries, please contact us at info@cpvs.co.uk Ph: +44 (0)800 246 1271