Bridging Science and Regulatory Excellence.
Working together to help you achieve pharmaceutical success through navigating compliance, and empowering Innovation.
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
At Montefiore Life Sciences (MLS), we help pharmaceutical, biopharmaceutical, and nutraceutical companies navigate global regulatory systems. Registered with the FDA, Health Canada, and EMA, we support your journey from development to market with expert guidance on submissions, facility licensing, and compliance strategy.
Who We Are
We offer regulatory consulting, submission support, and licensing services tailored to meet the demands of FDA, Health Canada, and EMA frameworks.
What We Do
A team of experienced scientists and regulatory experts, committed to precision, professionalism, and delivering results in a complex global landscape.
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.