Regulatory Submission

RA

Overview

Life sciences companies worldwide face operational challenges in meeting the stringent regulatory submission criteria by health authorities in order to demonstrate the safety and efficacy of their products. Athreva offers a comprehensive range of regulatory submission services with flexibility, scalability, and top-notch quality to save a significant amount of your valuable time and money. Our seasoned team of submission experts can assist with a potentially diverse array of end-to-end Regulatory Submissions process right from dossier development to timely submissions, supporting all kinds of formats- paper, electronic, eCTD or NeeS.

What We Offer

  • New Investigational and Marketing Applications – BLA, IND, NDA
  • Existing Investigational and Marketing Applications (Cumulative application review and assessment, Labeling submissions, Submission import and hosting, Baseline submissions)
  • Validation and Marketing Application Submission Services (Submission technical review and validation, STF and SPL review, Dataset hyperlink review, FDA ESG submission filing)
  • Dossier submission services to multiple health authorities
  • Regulatory intelligence services to interpret regional and national requirements for submissions
  • Comprehensive quality check and adherence to predefined SLAs
  • End to end services for Submission and Archival of Dossiers for multiple regions
  • Management and Submission of IND Safety & Adverse Event Reports
  • Review impact of glitches and missing data on the results of submission




Why Athreva

  • Detailed submission filing strategy from initial stages of compilation to lifecycle management
  • Region-specific timely and high-quality submissions
  • Constant project micro-management by team leads to avoid delay in submission
  • Multi-stage verification and quality review by experts
  • Adopted culture and ethics to maintain confidentiality of client information
  • 24 x 7 client support