Unlocking Pathways to Product Approval.
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.
Our team is also highly skilled in guiding new laboratory facilities through the process of acquiring GMP Drug Establishment Licenses (DEL) from Health Canada and preparing for FDA, EMA, and PMDA inspections and audits.
Obtaining GMP/GLP licenses and facility/product registration with the FDA and Health Canada
Expertise in compliance with GMP, GLP, ICH, USP, EP, and JP Guidelines
Preparation and management of ANDA, NDA, DMF, BLA, MAA, IND, and CTA submissions to regulatory authorities
Development and implementation of Standard Operating Procedures (SOPs) per GMP/GLP guidelines
Creation and enhancement of procedures for handling controlled substances and precursors
Vendor and laboratory audits for compliance and quality assurance
Quality control support and the development of method validation protocols
Management of all post-approval filings
Method development, validation, and transfer, from protocol approval to final report
Pharmaceuticals
At Montefiore Life Sciences, our experienced scientific team leverages their extensive expertise and innovative approaches to assist you in key areas such as Formulation, Method Development & Validation, and Analytical Chemistry. We offer a full range of analytical services, including HPLC/UPLC Assays, Mass Spectroscopy (LC/MS, LCMS/MS, GC/MS, ICP/MS), Dissolution/Elution/Drug Release Profiles, Finished-Product Release Testing, Stability Testing, Raw Material Testing, Extractable/Leachable Testing, Package Testing, and Elemental Impurities analysis.
Services
Analytical services for both small and large molecules
Bioanalytical and Biologics testing
Formulation development for all dosage forms
QC Release Testing
Dissolution Testing
In-vitro Drug Release Testing
Nutraceuticals
With years of experience in nutritional supplement testing, Montefiore Life Sciences provides comprehensive analytical services to ensure the accurate composition of active ingredients while testing for unwanted residues or contaminants. Additionally, we offer expert guidance on the legal and regulatory aspects of nutritional supplements to ensure compliance with global standards.
Services
Analytical testing
Sample testing for active ingredients and contaminants
QC Release Testing
Cosmetic product testing
Quality and regulatory compliance for US FDA and Health Canada standards
Label & Packaging Compliance