### **Overview** Jeevan Scientific Technology Limited (JSTL) is a leading full-service Contract Research Organization (CRO) headquartered in Hyderabad, India. With over two decades of experience, JSTL supports pharmaceutical, biotechnology, and healthcare companies across the global drug development lifecycle. The company has established itself as a trusted partner for bioavailability/bioequivalence (BA/BE) studies, clinical trials (Phase I–IV), pharmacovigilance, and advanced drug delivery R&D through its subsidiary, **Nayas Laboratories Private Limited**. JSTL combines regulatory excellence, scientific innovation, and operational efficiency to deliver high-quality, time-sensitive solutions for both generic and innovative therapeutics, including biosimilars, complex generics, and novel molecules. --- ### **Core Capabilities & Infrastructure** #### **1. Clinical Research & Trial Operations** - Conducted **approximately 666 clinical studies** across diverse therapeutic areas and dosage forms. - Offers end-to-end clinical development services from Phase I to Phase IV, including interventional and observational studies. - Specializes in complex trial designs, feasibility assessment, recruitment of specialized patient populations, and multi-country coordination. - Maintains an independent **20,000 sq. ft. USFDA/MHRA/WHO/CDSCO-inspected clinical pharmacology unit**, equipped with: - 4 wards (over 100 beds) - 2 special care units (3 beds each) - Glucose clamp technology and YSI analyzers - Automated volunteer management system - Dedicated ambulance and tie-ups with tertiary care hospitals - Focus on fast patient recruitment and rapid study completion to accelerate time-to-market for clients. #### **2. Bioanalytical Laboratory** - State-of-the-art NABL-accredited facility with: - 2 processing labs - 4 LC-MS/MS labs - **12 LC-MS/MS instruments** and 1 ELISA system (upgraded since 2021) - Cold chain storage: walk-in freezers at -70°C and -20°C - 21 CFR Part 11-compliant data logging systems - Successfully passed regulatory inspections by **USFDA, WHO, UK-MHRA, CDSCO**, and sponsor audits — validating data integrity and compliance. - Expertise in bioanalytical method development for **over 220 small molecules and 10 large molecules**, covering 250+ drugs or compounds. - Strong capabilities in handling **light-sensitive and complex molecules**, supported by a skilled scientific team. #### **3. In-House Pathology Laboratory** - On-site NABL-accredited lab for haematology, serology, biochemistry, and urine analysis, enabling efficient screening for clinical trial participants. --- ### **Growth Strategy & Business Expansion** #### **1. Geographic Expansion** - Targeting **multi-fold growth in FY2025–26** by expanding full-service CRO operations into **Latin America (LATAM), the Middle East, and Southeast Asia**. - Strategic regulatory accreditations obtained: - **NPRA (Malaysia)** - In progress: **ANVISA (Brazil)** and **GHC (Gulf Health Council)** - Aims to become a **one-stop shop for global pharma clients**, offering harmonized services across international markets. #### **2. Service Diversification** - Core growth drivers: **Clinical Trials, Pharmacovigilance, and BA/BE**. - Active expansion into high-complexity segments: - **Biosimilars** - **Large and sensitive molecules** - **505(b)(2) and Para IV applications** - Plans to introduce integrated offerings in: - **Clinical Data Management (CDM)** - **Biostatistics** - **Medical Writing** - Strengthening capabilities in **risk-based monitoring, real-world evidence (RWE), and digital clinical trials** using ePROs and virtual trial models. #### **3. Digital Transformation & Innovation** - Heavy focus on **automation, digitization, and AI-powered tools** to: - Reduce turnaround times - Enhance data accuracy - Improve audit readiness - Ensure regulatory compliance - Leveraging **big data and artificial intelligence** for signal detection and pharmacovigilance analytics. --- ### **Subsidiary: Nayas Laboratories Private Limited** - India’s **first CRO dedicated to Advanced Drug Delivery Technology Platforms** and **in-house development of patentable biomedical polymers**. - Offers full lifecycle services from concept to commercialization in: - Complex Generics - Novel Drug Delivery Systems - 505(b)(2) products - Polymer-based formulations - Equipped with advanced R&D infrastructure for formulation, analytical development, and regulatory support. - Positioned as a key enabler of JSTL’s innovation-led growth strategy in differentiated and high-margin segments. --- ### **Market Position & Industry Trends** #### **Industry Tailwinds** - Rising complexity in clinical trials due to stricter regulatory norms, specific patient criteria, and digital endpoints is driving demand for experienced, large-scale CROs. - Growth in **real-world evidence (RWE)** adoption using EMRs, insurance claims, and digital health tools to demonstrate therapy value amid rising R&D costs. - Increased outsourcing by global pharma firms to focus on core competencies — especially in regulated (US, EU) and emerging markets. - India's emergence as a preferred outsourcing destination due to **cost efficiency (~30–40% savings), skilled workforce, and strong ITES infrastructure**. #### **JSTL’s Competitive Edge** - **Regulatory Track Record**: Passed **16+ regulatory inspections** (up from 14 in 2022), including multiple international agencies. - **Global Service Reach**: Supports clients worldwide with compliant, high-quality data. - **Operational Excellence**: Focus on process orientation, lifecycle management, and customer retention. - **Strategic Flexibility**: Offers both end-to-end solutions and standalone/customized services. --- ### **Pharmacovigilance (PV) Leadership** - PV is a key growth pillar, with specialized services including: - ICSR processing - Literature screening - Signal detection (leveraging AI and big data) - Risk Management Plans (RMPs) - Preparation of PSURs, PBRERs, and PSMBFs - Operates a **24x7 Medical Information Call Centre (MICC)** powered by Ozonetel and Aavaz platforms, supporting global clients. - Based in **Hyderabad — a major pharmacovigilance hub in India** — with a dedicated team of physicians and PV experts. - Targeting small and mid-sized pharma companies with cost-effective, automated PV solutions. --- ### **Leadership & Expertise** - Led by **Dr. M. Rajendra Prasad**, a veteran CRO leader with deep expertise in clinical operations, BA/BE, data management, and regulatory compliance. - Team comprises experienced professionals across scientific, medical, regulatory, and technical domains with global project exposure.