Where Topical Innovation Meets Regulatory Success
Expert consultancy in IVRT and IVPT testing, regulatory strategy, and product lifecycle support for topical and transdermal drug development.
We work with
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American Food & Drug Association
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European Medicines Agency
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Health Canada
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PMDA Japan
Your Trusted Partner in Global Regulatory Compliance
Montefiore Life Sciences is a specialized consultancy delivering advanced in vitro solutions for topical and transdermal drug products. With deep expertise in IVRT (In Vitro Release Testing) and IVPT (In Vitro Permeation Testing), we support pharmaceutical, biopharmaceutical, nutraceutical, and cosmetic companies in developing regulator-ready strategies, executing reproducible studies, and accelerating global approvals.
Beyond our core specialization in IVRT/IVPT, we offer comprehensive services in regulatory affairs, GMP and quality systems, laboratory method development, analytical testing, technical training, and commercial strategy. Our integrated approach provides clients with end-to-end support across every stage of product development, submission, and lifecycle management.
Our services
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Analytical services for both small and large molecules
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Bioanalytical and Biologics testing
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Formulation development for all dosage forms
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Quality Control Release Testing
Regulatory Affairs and Compliance.
Our Regulatory, Compliance, and Quality Assurance specialists bring decades of experience working with government agencies, including the FDA, Health Canada, and the European and Japanese regulatory authorities. We assist pharmaceutical and nutraceutical operations in meeting regulatory and compliance requirements, ensuring adherence to GMP/GLP guidelines.