Nonclinical Regulatory Writing – An Overview

Nonclinical Regulatory writing strategy plays a crucial role in drug development. A well-planned preclinical drug development strategy not only saves time and money in the development of leads but also helps identify failed compounds at the early stages of development.

Freyr has experience bridging the scientific and nonclinical Regulatory writing requirements in such preclinical drug development strategies and nonclinical safety studies. From suggesting various registration pathways and strategic decisions to supporting nonclinical safety studies and nonclinical Regulatory writing, Freyr has trained expert toxicologists, scientific writers, and Quality Check (QC) personnel to support preclinical drug development and safety requirements. 

 

 

Nonclinical Regulatory Writing - Freyr Expertise

  • Strategic Decisions
    • Registration pathways.
    • Strategies for pre-Investigational New Drug (IND) and IND activities.
  • Nonclinical Safety Studies
    • Study conduct.
    • Good Laboratory Practice (GLP) facility audit and capability to conduct studies.
    • Preparation/review of study protocol/study plan.
    • Monitoring and auditing during the in-life phase of the study.
    • Study report review.
  • Nonclinical Regulatory Writing
    • High-quality Document Delivery.
    • Pre-IND Supporting Documents.
    • Investigator’s Brochure (IB).
    • Pharmacological Written Summary.
    • Pharmacological Tabular Summary.
    • Toxicological Written Summary.
    • Toxicological Tabular Summary.
    • Nonclinical part of IND package (electronic Common Technical Document [eCTD] module 2.4 and 2.6).
    • Preparation and Review of Nonclinical Overview (Module 2.4).
    • Preparation and Review of Nonclinical Summary/Summaries (Module 2.6).
    • Preparation and Review of the Nonclinical Study Report.
    • Preparation and Review of Nonclinical Protocol.
 

Nonclinical Regulatory Writing - Freyr Advantages

  • Qualified, trained, and experienced toxicologists and data scientists who come from diversified fields of toxicological research and have a thorough understanding of risk assessment.
  • Freyr’s staff has first-hand experience working in GLP environments as Study Directors and a fair understanding of the manufacturing process and Good Manufacturing Practice (GMP) requirements.
  • A robust quality control system associated with nonclinical Regulatory writing experts, which assures delivery of documents that are scientifically correct and audit/submission ready.
  • Freyr has an expert team that can deliver documents in almost half the time compared to the standard time in the industry for the same task.