Regulatory Affairs 3PO
FDA Third Party Review Unit dedicated to supporting medical device manufacturers
Our Regulatory Services
Comprehensive regulatory affairs services designed to navigate the complex FDA landscape and accelerate your product development timeline.
FDA 510(k) Third Party Review
Expert 510(k) reviews for Class I and eligible Class II medical devices through our FDA 3P510k pathway alignment
Medical Device Regulatory Strategy
Comprehensive regulatory strategy development for medical device manufacturers targeting U.S. market access
Quality Management Systems
Quality management systems aligned with FDA and ISO 13485 standards with rigorous compliance processes
Regulatory Compliance Reviews
Independent and expert evaluations of medical device submissions with transparent review processes
Data Security & Confidentiality
Advanced encryption technologies and secure digital platforms to protect sensitive client data
Global Market Access
Expertise in FDA processes with understanding of Indian and regional manufacturing landscapes
Our FDA Third Party Review (3PO) Team
Our FDA Third Party Review (3PO) Team comprises highly experienced regulatory professionals dedicated to delivering thorough, independent, and expert evaluations of medical device 510(k) submissions. We combine deep regulatory knowledge, practical clinical research experience, and rigorous quality management to ensure a compliant, efficient, and transparent review process.
Advantages of Partnering with an Indian FDA 3PO Organization
Cost-Effective Services: India's competitive cost environment enables top-tier regulatory reviews at significantly reduced fees
Time Zone and Cultural Alignment: Timely communication and collaboration with Asia-Pacific manufacturers
In-Depth Local Knowledge: Nuanced understanding of Indian and regional manufacturing landscapes
First-Mover Advantage: One of the earliest India-based FDA-accredited 3POs with unique market position
Scalable Expertise: Broad network of experts and consultants for efficient scaling without compromising quality
Advanced Technology: Streamlined workflows with automation to enhance review accuracy and reduce turnaround times
Our Expert Team
Led by seasoned regulatory professionals with extensive FDA experience and deep understanding of the Third Party Review Unit processes.
Rakshith Katta
Director – Regulatory Affairs
Experience: 12+ years
Over 12 years of global regulatory experience, including 8+ years consulting directly with the FDA in Washington, DC. MBA from Johns Hopkins University and Master's degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University.
Dr. Suresh Anand
Lead Reviewer
Experience: 20+ years
PhD from IIT Madras, specialized in biomedical optical spectroscopy and vascular dynamics. Over 20 years of expertise in medical device regulatory affairs, FDA 510(k) submissions, EU Technical Files, and global regulatory compliance.
Nancy Pavan
Lead Quality Assurance Consultant
Experience: 15+ years
Specializes in quality management systems aligned with FDA and ISO 13485 standards. Leads internal audits, manages CAPA processes, and coordinates SOP development and annex template creation.
Commitment to Data Safety and Process Efficiency
Data Security
SMO India is committed to maintaining the highest levels of data security and confidentiality. We utilize advanced encryption technologies and secure digital platforms to protect sensitive client data and submission materials.
Process Efficiency
Our streamlined workflows, supported by automation and technology, enhance review accuracy, reduce turnaround times, and ensure strict adherence to FDA regulatory requirements.
Contact Our Regulatory Affairs Team
Ready to accelerate your regulatory pathway? Contact our team of experts to discuss your specific needs and learn how our FDA 3PO partnership can benefit your project.
Contact Information
Important Note
Note: SMO India is in the process of seeking FDA Third Party Reviewer accreditation. No service is offered as accredited until FDA approval is granted.