VECTOR Life Sciences Ltd. (Pty)

VECTOR Life Sciences is a service provider for the African regulatory market with a key focus on the implementation and usage of electronic systems to improve regulatory efficiency. VECTOR supports both industry and regulators in their transition from paper based methods to electronic processes. ► Document Preparation – Prepare future oriented documents conform to current and future standards Are your documents CTD/eCTD ready? ► Document Management – Manage and maintain your regulatory documents in a document management system Are you conforming to the new ISO requirements for data storage? ► Submission Management – Compile and maintain your regulatory applications efficiently creating paper dossiers today that can be used electronically tomorrow Are you spending too much time preparing your applications? ► Submission Validation – Validate your applications and ensure they pass technical validation at agencies with electronic validation criteria Are your applications conform to technical specifications? ► Application Tracking – Track all your regulatory activities and registrations in all of your markets in a secure environment Are you on top of all your registrations? ► Transition Consulting – Ensure you do not overlook any aspects of moving from paper based methods to electronic processes Are you ready for your electronic regulatory systems? ★ Technical Experience Our IT team has been INSTALLING, VALIDATING and maintaining IT systems in South Africa for 22+ years, e-regulatory systems since in 2010 when the MCC introduced CTD/eCTD ★ Training Experience Our Training team has been providing regulatory TRAINING in South Africa for 15+ years. We have been active with CTD/eCTD compilation training in South Africa since its introduction in 2010 ★ Regulatory Experience Our CONSULTING team has been working in regulatory affairs in South Africa for 20+ years and has collectively worked with over 200 companies and 25 national authorities