JUNTOSVIDA Private Limited operates as a pharmaceutical research, development, and supply entity that specializes in generics, novel drug delivery systems-based generics, and the development of new products. We provide comprehensive finished product development services for high-potential molecules, overseeing the entire process from concept to commercialization. This is supported by robust technical assistance, technology transfer, and strategic licensing partnerships.

Quality serves as the cornerstone of our operations, which adhere to current Good Manufacturing Practices (cGMP). We utilize fully qualified instruments and validated systems, and we possess a proven track record in audits. Our approach integrates intellectual property strategy with exemplary formulation science, employing Quality by Design (QbD) methodologies to define Quality Target Product Profiles (QTPP) and Critical Quality Attributes (CQAs), thereby mitigating developmental risks.

Our expertise encompasses API process design and scale-up, as well as extensive analytical services, including adherence to USP, BP, EP, JP, and ChP methodologies, stability assessments, impurity analysis, polymorphism studies, and packaging compatibility evaluations. Additionally, we provide global Chemistry, Manufacturing, and Controls (CMC) regulatory support, which includes electronic Common Technical Document (eCTD) publishing and lifecycle management.

Moreover, we offer pharmacovigilance services, including Qualified Person for Pharmacovigilance (QPPV), Pharmacovigilance Organizational Infrastructure (PvOI), Pharmacovigilance System Master File (PSMF), Pharmacovigilance Master File (PvMF), and Pharmacovigilance Quality Management System (PV-QMS). Our capabilities extend to supply chain management, contract manufacturing, and technology transfer at sites compliant with WHO, EU GMP, US FDA, and TGA regulations, as well as clinical and bioequivalence study management conducted through our reliable Contract Research Organization (CRO) network.

Under the JUNTOSVIDA (IN-VITRO) brand, we provide In Vitro Release Testing (IVRT) and In Vitro Permeation Testing (IVPT) for topical products, Biopharmaceutics Classification System (BCS) classification, and biowaiver strategies. Our offerings include in vitro binding assays and advanced programs for the assessment of nitrosamines and elemental impurities, in alignment with ICH guidelines M7 and Q3D. Our competitive advantages comprise extensive regulatory expertise, state-of-the-art instrumentation, swift processing times, and integrated service models designed to expedite regulatory filings, facilitate market entry, and ensure ongoing compliance.