RBridge Lifesciences provides end-to-end regulatory support for pharmaceutical companies seeking market entry and lifecycle management across global regulated and semi-regulated markets. Our global regulatory services cover the full product lifecycle — from initial dossier strategy through to post-approval variation management.
What We Offer
- CTD Dossier Compilation
- ACTD Dossier Compilation
- Lifecycle Management
- Submission of Dossiers to Regulatory Health Authorities
- PSUR (Periodic Safety Update Report) Preparation
- SMPC (Summary of Medicinal Product Characteristics) Preparation
- Country-specific Dossier Preparation
- Post Approval Changes
- RMP (Risk Management Plan) Preparation
Our Approach
- Regulatory strategy developed based on target market requirements and product profile
- CTD/ACTD format ensures modularity and reusability across multiple country submissions
- Lifecycle management covers variations, renewals, label updates, and safety amendments
- PSUR preparation in line with ICH E2C(R2) and applicable health authority requirements