Business Imperatives

  • A USA-based pharmaceutical company approached Freyr for End-to-end aggregate reporting operations.
  • Freyr was approached as the client did not have the required SOPs, templates, and process documents to manage aggregate report creation and submission.

Objectives

To manage end-to-end aggregate reporting operations for generic pharmaceutical drugs in the therapeutic areas of Women’s Health, Gastroenterology, Infectious Diseases, Oncology, Immunology, and Established Drugs. This includes overseeing the entire process of collecting, combining, analyzing, and reporting data from multiple sources to provide comprehensive and actionable insights.

Problem Statement

  • The client did not have the required SOPs and templates.
  • The client lacked the required expertise and resources.

Freyr Solutions and Services

Freyr Solutions and Services
  • Provided experienced writers, QC specialists, medical reviewers, and subject matter experts (SMEs).
  • Maintained aggregate reporting calendars to keep track of both filed and upcoming reports.
  • Prepared aggregate reports as per HA requirements and collaborated with customers for review.
  • Utilized the in-house submission tool, SUBMIT PRO, for the submission of aggregate reports.
  • Interacted with HAs on behalf of clients for any queries and responses.
  • Aggregate Report Preparation: Based on the analysis, aggregate reports such as Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs) were prepared.
  • Medical Review: Subjected aggregated reports to thorough medical review by qualified healthcare professionals to ensure clinical accuracy and relevance.
  • Quality Check: Conducted comprehensive quality checks to ensure that the aggregate reports met Regulatory requirements.
  • Submission to Regulatory Authorities: Submitted the aggregate reports to the relevant Regulatory authorities within the specified timelines.
  • Supported End-to-end aggregate report operations.
  • Maintained 100% quality.
  • Achieved zero Regulatory rejections

Freyr successfully managed End-to-end aggregate reporting operations for the USA-based pharmaceutical company. The comprehensive reports enabled timely identification and management of any potential issues, supporting the company's commitment to maintaining high-quality standards.