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: priyanka@sygnetresearch.com

Sygnet Research

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