Services – Genorra Lifescience
Regulatory services and consultation
General - Regulatory Affairs
Comprehensive regulatory support from development through approval and lifecycle management for global markets
Strategic Regulatory Advisory
Regulatory risk identification and mitigation strategies.
Pre submission consultation with health authorities.
Global Dossier and DMF
New product registrations across regulated market (US, Europe and Canada) and semi-regulated countries (ROW) through dossier drafting and submission.
Post Approval Changes & Life Cycle Management
Support for change control assessments and submission of post approval changes including variations and lifecycle management activities.
Submission Management and eCTD Publishing
Global eCTD publishing and submission services covering the complete product lifecycle from initial submission life cycle management.
Regulatory Setup
DUNS, Establishment Registration (ER), Firm Establishment Identifier (EFI), Self-Identification, ESG setup assistance, CESP submission setup and country specific submission setup.
