The pre-clinical strategy for drug development plays a 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 failed compounds at early stages of development.

Freyr has both experience 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 and 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-Investigational New Drug (IND) 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)
    • Preparation and review of Nonclinical Overview (Module 2.4)
    • Preparation and review of Nonclinical Summary/Summaries (Module 2.6)
    • Preparation and review of Nonclinical Study Report
    • Preparation and review of Nonclinical Protocol

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 in almost half the time compared to the standard time in the industry for the same task
Global HA Mandates