Overview

The pre-clinical strategy for drug development plays crucial role in the process of drug development. A well-planned pre-clinical strategy not only saves time and money in the  development of  leads, but also helps to identify failure compounds at the early stages of development.

Freyr has both experience and capability in bridging  the scientific as well as Regulatory requirements in such pre-clinical drug development strategy and nonclinical safety studies. Right from suggesting various registration pathways and strategic decisions, to supporting nonclinical safety studies to nonclinical writing, Freyr has trained expert toxicologists, scientific writers and Quality Check (QC) personnel to support preclinical development and safety requirements. 

 

Freyr Expertise

  • Strategic Decisions
    • Registration pathways
    • Strategies for pre-IND (Investigational New Drug) and IND activities
  • Nonclinical Safety Studies
    • Study conduct
    • Good Laboratory Practice (GLP) facility audit and capability conduct study
    • Preparation/review of study protocol/study plan
    • Monitoring and auditing during the in-life phase of study
    • Study report review
  • Nonclinical 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
    • Non-clinical part of IND package (electronic Common Technical Document [eCTD] module 2.4 and 2.6)
 

Freyr Advantages

  • Qualified, trained and experienced toxicologists and data scientists who come from diversified fields of toxicological research and have through understanding of risk assessment
  • Freyr has staff with first-hand experience in working in GLP environment as study director and also have a fair understanding of manufacturing process and Good Manufacturing Practice (GMP) requirements
  • Robust quality control system associated with Regulatory writing experts which assures delivery of documents which are scientifically correct and audit/submission ready
  • Freyr has expert team which can deliver documents almost half of the time which is required in the industry for the same task