2RA Labs was founded by two seasoned professionals with deep expertise in pharmaceutical manufacturing, medical devices, and global quality systems. Their shared vision was to create a platform that supports innovation in drug delivery devices and pharmaceuticals through testing, regulatory guidance, and quality assurance services.
Drawing on decades of experience across pharmaceuticals, medical devices and global compliance frameworks, they built 2RA Labs to serve as a trusted partner for healthcare companies worldwide.
Founded 2RA Labs—not just as a service provider, but as a strategic partner to innovators, manufacturers, and regulators. Their goal is to elevate the standards of drug delivery through precision testing, robust regulatory support, and quality systems that withstand global scrutiny.
From verifying device performance and managing DHF documentation to executing supplier audits and navigating ISO 11608, ISO 13485, and GMP frameworks; 2RA Labs empowers healthcare companies to move faster, safer, and smarter.
Today, 2RA Labs stands at the intersection of science, regulation, and trust—driving the future of drug delivery with integrity, insight, and impact.
Rajesh Patel
Co-founder & Director – Operations, 2RA Labs
Bachelor of Engineering
He is co-founder and Director of Operations at 2RA Labs, where he drives global strategy, compliance, and supports for drug delivery platforms and pharmaceuticals services. With over 25 years of leadership in pharmaceuticals companies such as Alembic, Ranbaxy, Glenmark, Dr. Reddy’s, he drives strategic execution, safety, and continuous improvement across regulated environments for manufacturing of drugs and medical devices. He has expertise in technology transfer, new product development, scale-up, and regulatory alignment.
Prior to 2RA Labs, Rajesh led Healthcare Operations at Shaily Engineering Plastics, overseeing platform device manufacturing with a focus on safety, environmental stewardship, and global standards. His operational insight and process innovation continue to shape 2RA’s scalable, compliant, and patient-centric solutions.
Rashmikant Patel
Co-founder & Director – Quality, 2RA Labs
Master of Pharmacy
He is co-founder and Director of Quality at 2RA Labs, with over 13 years of experience in pharmaceutical and medical device quality assurance. He leads regulatory strategy, compliance systems, and quality operations across global standards including ISO 13485, ISO 11608, and cGMP.
Prior to co-founding 2RA Labs, Rashmikant held a managerial role in Quality at Shaily Engineering Plastics, where he led audits, regulatory certifications, and design verification for platform medical devices. His expertise spans vendor qualification, DHF review, and implementation of robust QMS frameworks in pharmaceuticals companies such as Sanofi, Zentiva, Cadila, J.B. Chemicals. He brings precision, integrity, and continuous improvement to every stage of product development and delivery.
To deliver world-class testing, validation, regulatory, and quality services that ensure the safety and compliance of medical devices and combination products—empowering clients to launch innovative healthcare solutions with confidence.
To be a trusted global partner in advancing drug delivery technologies, setting new standards in device testing, regulatory excellence, and patient safety.
Specialized Expertise
Experienced in testing Pen injectors, Autoinjectors, Pre-fillied Syringes, OBDS, and drug delivery systems.
Advanced Technology
Mecmesin platforms, Mirco balance, High-speed cameras, and custom fixture (21 CFR Compliance).
Collaborative Approach
Transparent reporting and strategic client partnership.
Comprehensive Services
Design verification, GMP audits, and MDR applications — all in one place.
Trusted & Reliable
ISO 11608 & 17025-compliant processes for accurate, repeatable results.
Global Regulatory Knowledge
Expertise in worldwide medical device standards.
Device Validations
Years Expertise
Regulatory Projects
Satisfaction Rate
To ensure the safety, reliability, and compliance of medical devices and combination products by delivering world-class testing, validation, and development services. Through scientific expertise, regulatory knowledge, and cutting-edge technology, Empowering clients to bring innovative and effective healthcare solutions to market with confidence.
To be a trusted global partner in advancing drug delivery technologies, driving innovation in medical device testing, and setting new benchmarks for regulatory excellence and patient safety. We aspire to lead the industry with integrity, precision, and a commitment to improving healthcare outcomes worldwide.
