Sygnet Research jobs and careers

About Sygnet Research

Sygnet partners with pharmaceutical, life sciences, medical device, and biotech organizations, providing quality-driven oversight, execution excellence, and compliance confidence. We work with Sponsors and CROs to strengthen study conduct, documentation integrity, and inspection readiness—helping programs progress with clarity, control, and credibility. ✅ Our Core Services 🔹 GCP (Good Clinical Practice) Key areas: • Monitoring of BA/BE studies using a Risk-Based Monitoring (RBM) approach – Real-time monitoring – Retrospective monitoring (audit) • CRO system audits • Inspection readiness support • Study documentation review & oversight 🔹 Project Management – BE Studies & Multicentric Clinical Trials Key areas: • Sourcing of RLDs (Reference Listed Drugs) • End-to-end project management of BE studies • Feasibility assessment, vendor/site alignment & operational readiness • Phase II–IV clinical trial management support, including monitoring and sponsor oversight • Milestone-driven execution with emphasis on on-time delivery 🔹 Regulatory Affairs & Strategies Key areas: • NOC from CDSCO • Marketing Authorization Application (MAA) submissions • Post-approval submissions • Scientific Expert Committee (SEC) presentation support & approval • Regulatory query support related to submissions • Gap assessment for dossier extension 🔹 Medical & Safety Writing Key areas: • Clinical and non-clinical module writing • Protocols, synopses, and study documents (CRF, ICF, patient diary, study plans) • Safety and periodic documentation support (project-based) • Risk Management Plans ⭐ What Makes Sygnet Different? • Over 30 years of combined industry experience • Trusted expertise across all functional areas • Consulting-led delivery with practical, scalable solutions • Strong compliance mindset aligned with global expectations 📍 Ahmedabad, India | Supporting India & Global Programs 📩 For collaborations & business queries: [email protected]