At PRETOX CONSULTANCY (PTC), we offer expert preclinical project monitoring to ensure your studies are conducted with precision, compliance, and scientific integrity. Acting as a monitoring scientist on behalf of the sponsor, we oversee every stage of the study—from protocol design to final report review.
Our role is to ensure that each preclinical study meets GLP standards, maintains timelines, and delivers reliable, reproducible data suitable for regulatory submissions.
Identification, planning, execution, monitoring, and interpretation of preclinical studies: Pharmaceutical/Medical device/agricultural productss
- Experienced in performing facility audit for CRO qualification
- Negotiation of study cost with CROs
- Evaluate the toxicity aspect with finalization of dose selection and experimental design
- Monitoring of preclinical safety studies from study initiation (study plan) to completion (study report) at different Contract Research Organization.
- Interpretation of toxicity results and correlate the toxicity findings with human clinical trials.
1. Pharmaceutical Product Testing (OECD GLP /ICH/NDCT/EMA ):
In vitro studies:
- Ames Test
- CA Test
- Micronucleus Test
In vivo studies:
- Acute
- MTD study
- GPMT study
- Subacute Toxicity
- Chronic/Sub-chronic
- Developmental and Reproductive Toxicity (segment I, II, III)
- Inhalation Toxicity
- Ocular Toxicity
- Carcinogenicity
- Pharmacokinetic and Tissue Distribution studies
2. Agricultural Product Testing (ISO):
- Acute tox study in Rats by oral
- Acute tox study in mice by oral
- Acute tox study in Rats by inhalation
- 90 days repeated dose toxicity study in rats by inhalation
- 90 days repeated dose toxicity study in rat by oral
