NAYARAi™
Pioneering healthcare regulatory excellence
Vision
To bridge gaps in global regulatory landscapes with regulatory intelligence and provide dexterity to industry leaders with expert regulatory solutions for product marketization.
Our Core Values
Ethics
We operate with uncompromising integrity, ensuring every action aligns with regulatory standards and ethical responsibility.
Reliability
Consistent, dependable execution you can trust—delivering accurate outcomes across every stage of the regulatory journey.
Partnership
We work as an extension of your team, building long-term relationships focused on shared success and growth.
Responsibility
We take ownership of every decision and outcome, ensuring compliance, safety, and accountability at all levels.
Accuracy
Precision-driven processes that minimize risk and ensure every submission meets the highest regulatory expectations.
Transparency
Clear communication and complete visibility across processes, enabling informed and confident decision-making.
Honesty
We provide straightforward guidance grounded in facts, prioritizing long-term trust over short-term convenience.
Accountability
Measured outcomes, clear ownership, and a commitment to delivering results you can rely on.
Process Excellence
Structured, optimized workflows designed to enhance efficiency, reduce delays, and ensure regulatory success.
Leadership & Expertise
Prathap Raja Varma
About
Prathap is a rare confluence of clinical pharmacologist, safety scientist, and regulatory architect — a professional whose career has been shaped at the sharpest edge of global healthcare innovation. With a Doctor of Pharmacy and a Master of Science in Regulatory Affairs, he brings a depth of scientific and regulatory literacy that few in the industry can match.
Born from a decade of frontline clinical experience and high-stakes regulatory practice across the United States, European Union, and India, Prathap founded NAYARAi™ with a singular conviction: that world-class regulatory intelligence should be accessible, strategic, and powered by the science behind it. He has personally orchestrated some of the most technically demanding regulatory pathways in existence — including Class III PMA submissions, EU MDR 2017/745 CE Marking, and global commercialization strategy across six regulatory jurisdictions.
At NAYARAi™, Prathap is not simply a consultant — he is your strategic partner, your regulatory conscience, and your most powerful advocate before the world's most demanding authorities.
Areas of Expertise
Clinical Pharmacologist
Prathap's clinical roots run deep — from individualizing complex oncology regimens and leading clinical pharmacology departments at premier cancer centers, to authoring Investigator Brochures and providing real-time clinical decision support. He has managed over 2,500+ patients across chemotherapy, immunotherapy, biologics, and injectables, bridging the critical gap between bench science and regulatory dossier.
Post-Market Surveillance & Safety Scientist
With a career defined by vigilance, Prathap has authored Safety Monitoring Plans, overseen MDRs, managed PMCF plans, and led safety surveillance programs for Class II and Class III medical devices. His command of adverse event frameworks — across both pharma and medical device sectors — makes him an unmatched asset for PMS strategy and compliance.
Medical Device Regulatory Expert
From 510(k) and De Novo to the most rigorous PMA and PMA Supplement pathways, Prathap has delivered regulatory approvals for some of the most advanced implantable and life-sustaining medical devices in the world. His expertise spans design control, risk management (ISO 14971), GSPR authoring, EUDAMED registration, and full EU MDR 2017/745 technical file strategy.
Software as a Medical Device (SaMD)
A forward-thinking regulatory expert with hands-on SaMD experience, Prathap has led 510(k) Exempt strategy and full regulatory compliance planning for digital health applications — developing traceability matrices, URS documentation, and SOPs to navigate the unique demands of AI and software-driven device regulation under FDA and IMDRF frameworks.