Regulatory Excellence
Expert CDSCO Navigation for Faster, Compliant Drug Approvals
eteraflex connects provides end-to-end regulatory affairs services specializing in CDSCO consulting, drug approvals, and clinical trial regulatory submissions. With 150+ approvals, a 98% first-submission success rate, and 4–5 week clearance timelines, we help pharmaceutical, biotech, and medical device companies navigate India’s regulatory system with confidence.
Regulatory Affairs Services for Every Stage
eteraflex connects provides a unified framework for regulatory consulting, offering scientific, strategic, and compliance support across the full lifecycle of product development.
Our services cover regulatory approvals for drugs, biologics, medical devices, and clinical trials, including pathway evaluation, dossier preparation, and authority engagement.
Our solutions span preclinical consultation, regulatory strategy, CDSCO submissions, post-market compliance, and long-term regulatory maintenance.
Our Regulatory Excellence
Regulatory Excellence for Drugs, Biologics & Medical Devices
Our India-based regulatory programs deliver complete lifecycle support through:
CDSCO Regulatory Excellence
Specialized expertise enabling accelerated clearances and high approval success rates.
Strategic Regulatory Development
Lifecycle support from preclinical planning to post-market compliance.
Clinical Trial Regulatory Support
End-to-end regulatory services for trial approvals, submissions, and safety reporting.
Medical Device Pathways
Optimized strategies for device classification, CER preparation, and PMCF oversight.
Our services provide strategic positioning, risk mitigation, and compliant submissions across drug, biologic, and device categories.
How We Deliver
eteraflex connects ensures seamless regulatory execution through a structured and transparent operations framework:
- Accelerated Approval Timelines: CDSCO clearances in 4–5 weeks (vs industry 12–16 weeks)
- Regulatory Strategy Development: Pathway modeling, competitive intelligence, and risk-benefit analysis
- Submission Expertise: 150+ successful approvals and systematic query-resolution methodologies
- Authority Engagement: Meeting representation, advisory committee preparation, and communication strategy
- Clinical Trial Regulatory Support: Protocol review, EC coordination, amendments, and safety reporting
Our integrated approach ensures faster approvals, reduced risks, and consistent submission quality.
Technology & Quality
Regulatory Intelligence Systems — Built for Speed and Compliance
eteraflex connects leverages structured regulatory frameworks and technology-enabled processes to achieve high approval success.
Platform Advantages
- 4–5 week approval timelines
- 98% first-submission approval rate
- Systematic dossier preparation methodologies
- Proven acceleration for manufacturing licenses (6–8 weeks)
Quality & Compliance Framework
- Zero critical audit findings across 150+ submissions
- Risk-based regulatory planning and compliance monitoring
- Comprehensive submission tracking and authority communication
- Continuous improvement through regulatory intelligence and insight
A Trusted Regulatory Network Across India
Our regulatory operations integrate with government agencies, CDSCO officials, ethics committees, and notified bodies — ensuring faster decisions, stronger communication, and smoother approval cycles.
Robust Regulatory Infrastructure
Established CDSCO relationships and structured communication protocols.
High-Performance Authority Engagement
Proactive query management and rapid resolution frameworks.
Standardized Quality Frameworks
Unified submission standards ensuringconsistency and compliance across all dossiers.
