Shiwatrix Lifesciences is a specialized scientific and regulatory consulting firm supporting the medical device and pharmaceutical industries with evidence-based solutions and internationally accredited expertise. Scientific excellence and regulatory precision sit at the core of everything we do.
Our internationally accredited toxicologists and regulatory specialists bring over 20 years of professional experience, helping clients navigate complex regulatory requirements with confidence.
Our original group of accredited toxicologists expanded into a full multidisciplinary team, and our regulatory reach broadened along with it — from an early focus on ISO 10993 biological evaluations to today's coverage of FDA, European MDR, UK, CDSCO, and FASC requirements across emerging global markets. Along the way we built out a complete service offering — Biological Evaluation Plans and Reports, Chemical Characterization, and Toxicological Risk Assessments — delivered through a disciplined process of consulting, assessing, documenting, supporting, and responding to every challenge a submission raises. With 250+ projects delivered for 80+ clients worldwide and a team anchored by ERT and DABT-certified toxicologists, we continue investing in the accredited expertise it takes to help healthcare innovations reach patients safely, faster, and in full compliance with international standards.
To be a trusted global leader in scientific and regulatory consulting, enabling healthcare innovations to reach the market safely and in compliance with international standards.
To provide reliable, science-based solutions that support product safety, regulatory excellence, and business success through quality, integrity, and innovation.
Our team's strength lies in the depth and breadth of its scientific and regulatory experience. With over two decades of professional practice, our internationally accredited toxicologists and regulatory specialists have guided clients through some of the most demanding regulatory frameworks in the world, including ISO 10993, ISO 14971, FDA guidance, and European MDR.
Our multidisciplinary team of clinical experts, regulatory professionals, and internationally accredited toxicologists delivers tailored solutions while maintaining the highest standards of quality and scientific integrity. Every assessment that leaves our desk has passed through hands that hold real, internationally recognized credentials — including ERT and DABT certification — so clients can be confident in the science behind every conclusion.
Every conclusion we reach is grounded in rigorous, defensible science, never assumption.
We hold ourselves to the same exacting standards we help our clients meet.
We work alongside our clients as an extension of their team, not just an outside vendor.
Our expertise spans regulatory frameworks across multiple regions and markets.
Regulatory science evolves constantly, and so do we — staying current so our clients always do too.
Behind every Shiwatrix Lifesciences report is a team of internationally accredited toxicologists and regulatory specialists with three decades of combined expertise, a track record of 250+ successfully delivered projects, and a client base of 80+ organizations across the globe. That combination of accreditation, experience, and consistency is why manufacturers trust us with their most safety-critical decisions.
Talk to our regulatory and scientific experts today.
Assign a Session