Regulatory Publishing

Scientific Branding Services

Overview

As a committed global regulatory service provider, Athreva can assist pharmaceutical companies to obtain timely approvals for their manufactured products from region-specific health authorities (HAs). Our curated team of Regulatory Publishing Services experts are proficient in delivering efficient and cost-effective regulatory operations which include submission management/ planning, publishing strategy, document level publishing (DLP), submission level publishing (SLP), and translating your complex data and results into formatted submission-ready documents based on ever-changing HA requirements.

With a proven expertise in eCTD, Non-eCTD (NeeS), PDF and paper submission formats for both pre-approval (original application, amendment to original application) and post approval (variations/ supplement, annual report and PSUR/ PADER) data globally, we can help you navigate through stringent HA guidelines with a suite of streamlined end-to-end regulatory publishing services.

What We Offer

In an ever-changing regulatory landscape, Athreva strives to stay at the forefront of paper and electronic submission requirements on a qualitative note at an affordable rate and with quick turnaround time. We provide inclusive regulatory publishing services to Pharmaceuticals, Biopharmaceuticals, Healthcare, CMO and Clinical Research industry and deal with both regulated and semi-regulated markets. Our meticulously picked Regulatory Publishing team ensures that documents are formatted using standardized industry templates with appropriate granularity and formatting consistency across the dossier, resulting in a right first time approach. As your trusted publishing partner, Athreva offers the following Regulatory Publishing services:



  • End-to-end services for Publishing, Quality Control, Submission review, and Archival of Dossiers for multiple regions
  • Global dossier compilation services
  • Conversion of paper dossier (e.g., DMFs) to NeeS to eCTD format in line with HA guidelines worldwide
  • Compliance quality check and adherence to predefined service-level agreements (SLAs)
  • Industry standard electronic submission publishing software
  • Expertise in tackling common hurdles such as formatting and hyperlinking issues, floating sections, and error corrections
  • Comprehensive tracker to keep a tab of all version changes throughout a publishing project lifecycle
  • Elaborate eCTD publishing roadmap to assess and monitor progress of original submissions and maintain lifecycles


Why Athreva

  • Regulatory intelligence consultation and services to interpret region-wise requirements for submissions and stay abreast of ever-changing regulations
  • Proven high-quality software solutions to deliver compliant, timely and affordable publishing services
  • Secure Electronic Submissions and Web-based Document Review
  • Readily available strategic, process, and technical advice
  • Flexible availability of resources
  • Centralized process development lifecycle
  • Right-first-time delivery which ensures error free documents