Montefiore Life Sciences
Montefiore Life Sciences is a specialized pharmaceutical consultancy headquartered in Stoney Creek, Ontario, with operations in Barcelona, Spain. We focus exclusively on IVRT (In Vitro Release Testing) and IVPT (In Vitro Permeation Testing) — two of the most technically demanding and regulator-preferred methodologies for assessing topical product performance and establishing bioequivalence.
We work with pharmaceutical and biopharmaceutical companies when precision, reproducibility, and regulatory alignment are critical — particularly in cases where internal testing programs are underperforming or have failed to meet method validation, QA, or submission-readiness standards.
Out Team
What sets Montefiore apart is our ability to operate flexibly and transparently. Our scientists can work directly within your facility, guiding or executing method development and testing using your in-house infrastructure, or we can conduct studies through our network of GMP-accredited partner laboratories. From method development and validation to bioequivalence assessment, stability testing, and regulatory submission preparation, we offer comprehensive support built on industry best practices and real-world experience.
Our team has direct experience designing IVRT/IVPT protocols that have been reviewed and accepted by regulatory authorities including the FDA, EMA, and Health Canada. We understand the practical challenges companies face when data reproducibility, method validation, or audit-readiness is on the line — and we respond with proven, science-driven solutions.
Scientific Values & Industry Foundations
Montefiore Life Sciences was founded by professionals with extensive backgrounds in GMP laboratory operations, analytical method design, and global regulatory strategy. Our foundation is built on two core strengths: the regulatory rigor of North American compliance frameworks and the scientific innovation of European pharmaceutical development.
We work side by side with R&D, QC, and regulatory teams to ensure that in vitro testing strategies are scientifically sound, submission-ready, and fully aligned with regulatory expectations from the outset.
Our work is guided by three principles:
Scientific precision with regulatory foresight
Process transparency and operational flexibility
Data integrity that stands up to inspection and review
If your product demands a reliable in vitro strategy — Montefiore provides the expertise, infrastructure, and regulatory understanding to deliver it.