A technology driven approach to regulatory publishing, supported by Wipro’s expert team
Regulatory Publishing and Submission in the pharmaceutical industry deals with authoring, maintenance and submission of various type of documents to regulatory authorities globally for drug approval and post approval requirements. These submissions are performed in various formats such as eCTD, CTD, eDOK or NeeS. Pharmaceutical companies face operational challenges in meeting the stringent regulatory submission criteria. Wipro offers comprehensive regulatory submission services with technology, flexibility, and scalability with quality driven process to save your valuable time and money.
Regulatory Publishing & Submission @ Wipro
- Document level publishing and submission level publishing
- Expert knowledge of all regional dossier formats, standards, navigation and lifecycle management
- Regulatory expertise around electronic submission structure and content related to drug development and post approval requirement
- Standardization of best practices for regulatory submissions to ensure consistency (e.g., technical evaluation, implementation and documentation of regulatory content, submission procedures/guidance, submission integration, and submission tracking)
- Compilation, publishing and submission of documents for new investigational and marketing application such as CTAs and INDs and related amendments, MAAs, NDA, ANDA and BLAs and related variations and for other health authorities.
- Review and gap analysis of regulatory documentation prepared by other professionals intended for submission to regulatory authorities
- Compilation, publishing and submission of documents for existing marketing application
- Compilation, publishing and submission of PSURs, HA responses, variations and renewals
- Handling technical interactions with HA and documenting them
- Ensuring eCTD readiness in collaboration with Regulatory System and Data Management
- Regulatory intelligence services on interpreting regional/national publishing and submission requirement
- Availability of regulatory publishing and submission technology platforms
