Nonclinical Regulatory Writing
The well-planned pre-clinical strategy for drug development plays a crucial role in the process of drug development, which helps to identify failed compounds at early stages of development.
Revive has both experience in bridging the scientific as well as Regulatory requirements in pre-clinical drug development strategy and nonclinical safety studies. Revive has expert toxicologists, scientific writers and Quality Check (QC) personnel to take strategic decisions that supports preclinical development and nonclinical writing with safety requirements
REVIVE Motto:
- 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