Robust oversight of CRO partners with preferential allocation of study slots at competitive rates, ensuring timely and cost-effective study execution.
A highly qualified team comprising Registered Nurses, research scientists (PhDs), and medically trained professionals, including advanced degrees in dentistry and pharmacology, with an average of 15+ years’ experience.
Expert consultation for the development of new molecules, providing in-depth research, clinical evaluation, and strategic guidance for in-source or licensed products aligned with client objectives.
Comprehensive clinical solutions and services across trials,
regulatory compliance, pre-clinical studies, and scientific advisory.
Full lifecycle management of clinical trials, BE studies, and animal studies.Monitoring to ensure protocol adherence, regulatory compliance, and quality standards.
Preparation of safety reports, including PDE/OEL and annual submissions.Responses to regulatory queries, SmPC & PIL reviews, and regulatory consulting (505(b)(2)).
Management of pre-clinical and in vitro studies.Dissolution evaluation, IVIVC recommendations, and quality-by-design procedure implementation.
Expert Toxicology Writing for Compliant, Scientifically Sound Product Documentation.
Permitted Daily Exposure (PDE)/Occupational Exposure Limits (OEL) Health-Based Exposure (HBEL) Report Preparation of Non-Clinical and Clinical Sections (2.4 and 2.6) as per ICH guidelines Impurity qualification as per ICH requirements (ICH M7), including nitrosamines Risk Management Plan (RMP) and CCDS –preparation of the non-clinical section Biocompatibility Risk Assessment (BRA) Toxicological Risk Assessment (TRA) Gap Analysis BiologicalEvaluationPlan (BEP) Preparation of Cosmetic Product Safety Report (CPSR) Preparation of raw material (RM)/ Ingredient toxicological profiles Exposure and Margin of Safety (MoS) calculations Proposition 65 calculations Fragrance and Flavours assessmentLife science background and DABT and ERT certified Toxicologist with 8+ years of experience.
Development of clinical, regulatory, and promotional documentation.
Comprehensive ambulatory support and strong vendor oversight with CRO audits and due diligence.Preferential allocation of study slots at competitive rates.
GCP and GxP training programs to ensure high-quality study conduct. 
Expert consultation for clinical development of new molecules.Assessment of research and clinical viability for in-source or licensed products aligned with customer objectives.
Copyright © 2026 Pivot Path Private Limited. All rights reserved.