### **Overview** TAKE Solutions Limited (TSL) is a publicly listed, domain-intensive services and technology company operating primarily in the **Life Sciences, Software, and Information Technology** sectors. The company is recognized as **India’s only publicly listed full-service Clinical Research Organization (CRO)**, with Life Sciences accounting for over 90% of its total revenue. TSL provides end-to-end services across the pharmaceutical product lifecycle—spanning clinical trials, regulatory affairs, pharmacovigilance, safety, and post-marketing surveillance—supported by a suite of proprietary technology platforms and analytics. As of March 31, 2025, **TAKE Solutions Pte Ltd (Singapore)** holds a **controlling 52.90% equity stake** in the company, retaining authority over strategic operating and financial policies. --- ### **Core Business Segments & Service Offerings** #### **1. Life Sciences – Full-Service CRO (Navitas Group)** TAKE Solutions, through its life sciences arm—including subsidiaries such as **Navitas Life Sciences**, **Ecron Acunova**, and **Navitas Data Sciences**—operates as a full-service CRO serving global pharmaceutical, biotech, and medical device clients. **Key Service Areas:** - **Clinical Trial Management (Phases II–IV):** End-to-end execution focusing on speed, cost-efficiency, and quality-by-design. - Feasibility assessment, study start-up, project management - Risk-based monitoring (on-site and centralized) - Data management, biostatistics, and medical writing - Pharmacovigilance and regulatory publishing - **Bioavailability/Bioequivalence (BA/BE) Studies:** - Conducts complex studies including multi-drug inhalation, euglycemic clamp, PK/PD in special populations - Operates **four advanced clinical facilities** in **Bangalore, Mangalore, Manipal, and Chennai**, with a combined capacity of over **300 beds** - Over **25,000 healthy volunteers enrolled** to date - **Specialized Clinical Trials:** - Non-interventional studies (NIS), post-authorization safety studies (PASS), market surveys - Medical imaging services (central review, site training) for global Phase I–IV trials - Controlled drug delivery and novel inhalation study capabilities #### **2. Regulatory Affairs** - Over **70% of regulatory filings** submitted to **U.S. FDA**, followed by **EMA and Health Canada** - Facilitated **over 180,000 regulatory submissions** globally - Proprietary **eCTD and SPL submission platform: pharmaREADY®** used by **200+ active clients globally** - Backward-compatible, cloud-based, compliant with 21 CFR Part 11 and global standards - Modules for document management, training records, and submissions - Five proprietary intellectual properties (IPs) in regulatory affairs - Maintains **~5% market share in U.S. FDA regulatory submissions (2012–2020)** with **90% customer retention** #### **3. Pharmacovigilance & Safety** - Full lifecycle safety services: from clinical trial monitoring to post-marketing surveillance - Centralized SOPs and multi-tenancy Argus database deployment - **300+ safety consulting engagements** completed - Two proprietary IPs in PV; safety analytics dashboards for client KPI tracking - Supported **pharmaceutical clients across all geographies**, including complex database migrations and upgrades #### **4. Data Sciences & Technology Platforms** - **OneClinical Analytics**: AI/ML-powered cloud platform for real-time clinical data visualization, monitoring, trial optimization, and risk mitigation. - Reduces clinical trial costs by **25%**, lowers quality risks by **20%**, cuts data standardization time by **>50%** - Enables remote monitoring, hybrid/virtual trials, and outcomes-based engagement models - **Cloud-based systems**: eDC, LIMS, imaging, and biostatistics tools - Implemented **remote site management** during the pandemic, ensuring continuity --- ### **Global Presence & Operations** - **Headquarters**: Chennai, India - **Global Footprint**: 14 international offices across **6 countries** (India, USA, UK, Singapore, Malaysia, Colombia) - **Subsidiaries** (Feb 2024): - Ecron Acunova Limited - Navitas LLP - TAKE Solutions Limited ESOP Trust - TAKE Consultancy Services Inc (USA) - **Facilities**: - **Three GLP and 21 CFR Part 11-compliant bio-analytical labs** with LC-MS/MS, ICP-MS, and LBA technologies - Labs are **NABL (ISO15189:2012) and CAP accredited**, ensuring high-quality standards - Five regulatory hubs across six countries --- ### **Technology & Innovation** - **Proprietary Platforms**: - **pharmaREADY®**: Regulatory submission and compliance platform - **OneClinical Analytics**: AI-driven clinical trial management - **safetyREADY®**: Pharmacovigilance and safety database management - **Eight unique technology IPs** developed for life sciences - **Automated data migration tools**: Enable seamless transfer of legacy documents, submissions, and labels - Hosts **10 proprietary industry network forums (NETS)** with **>120 member organizations**, including top pharma companies - Over **17 years of benchmark data**, 81 case studies, 7 white papers, and 26 global meetings conducted --- ### **Client Base & Market Positioning** - Serves a diverse global clientele including: - **Innovator biopharmaceutical companies** - **Generic drug manufacturers** (serves **>50 global generics firms**) - **Mid-sized biotechs and specialty pharma** - **Regulatory agencies** (e.g., CDC, DoD) - Strong focus on **regulated markets**: ~87% of revenue from the **U.S. and Europe** - Differentiator: **Integrated services** across **clinical trials, regulatory, and safety domains**—a niche where most competitors lack presence --- ### **Strategic Developments** #### **Divestiture & Restructuring (2021)** - In September 2021, TAKE Solutions completed a strategic transaction with **H.I.G. Capital**, a global alternative investment firm with $45B AUM. - **H.I.G. acquired a 75% stake in Navitas Life Sciences** for **USD 101.63 million** ($91.63M cash + $10M seller note, 6% PIK) - Objective: To **restructure Navitas as a standalone, next-gen CRO** and **deleverage TAKE’s balance sheet** - Transaction enabled TAKE to focus on core life sciences and technology offerings #### **Expansion & Acquisitions** - Expanded global footprint through acquisitions: - **Ecron Acunova (2016)**: Gave full-service CRO capabilities - **Dataceutics (2019)**: Now Navitas Data Sciences, strengthened FSP offerings - **KAI Research (2019)**: Added clinical research expertise - Subsidiaries established in **USA, UK, Germany, Poland, Russia, Denmark, Malaysia, and Singapore** #### **Exit from Non-Core Businesses** - Exited joint ventures in **Supply Chain Management** (Oman, India with APA Engineering) to focus on life sciences - Engineering and SCM services now represent a minor revenue stream --- ### **Regulatory & Quality Excellence** - Successfully passed **over 40 regulatory audits** (as of July 2024) including **FDA, DCGI, NPRA Malaysia**, with a history of **zero critical findings** - Compliance with **GCP, GLP, 21 CFR Part 11, ISO 9001:2015, and ISO 27001:2013** - Over **20 therapeutic area expertise** and clinical trial experience in **>30 countries** --- ### **Workforce & Expertise** - Employed **over 1,500 professionals** as of 2021–2023 - **>60% of specialists hold advanced degrees (Ph.D., Master’s)** - Includes **180+ industry specialists**, with **30% being domain experts** (MDs, PhDs, biostatisticians) having **>10 years’ experience** - Leadership includes **Mr. Srinivasan H.R. (Vice Chairman & MD)** and experienced professionals from **Novartis, Pfizer, GSK, and AstraZeneca** --- ### **Recent Achievements (2020–2023)** - **Handled 9+ COVID-19 clinical trials**, including one leading to emergency use authorization in India - Completed **DECODE COVID-19 study in <3 months**—faster than industry benchmark - Secured **$7M+ in rare disease research contracts** and **$5M+ in specialty pharma deals** - Launched **complex pharmacovigilance solutions in Canada** and **upgraded large-scale safety databases** - Delivered **one of the largest PV tech implementations** for SME pharma --- ### **Listing & Governance** - **Publicly listed** on **BSE and NSE (India)** - **Board of Directors**: 8 members, including **5 independent directors** - Recognized for **strong corporate governance**, strategic leadership appointments, and transparent investor communications