Neopharm Labs - Quebec CA Laboratory

Overview

About Neopharm Labs

Serving the Life Science industry for 25 years, Neopharm is a full service GMP analytical testing laboratory closely collaborating with pharmaceutical, medical devices, natural health, medical marijuana, veterinary as well as cosmetic clients. As Science experts, we have a unique platform to provide complete portfolio to Life Science industry including: chemistry, microbiology including sterility, quality control, R&D support, ICH stability studies, method validation and transfer, as well as Quality Assurance and Regulatory Affairs services.

Our world-class laboratory is regularly inspected by government agencies such as the U.S. FDA and Health Canada, and has been qualified by several world-renowned Life Science industry leaders. Our laboratory provides services for Canada, U.S. and Global customers since Canada is a privileged participant to the Global Mutual Recognition Agreements (MRA's). Countries where MRA's are in place will accept Certificates of Analysis (CofA's) emitted by our laboratory for the local commercialization of foreign products.

Unmatched capacity

Located on the outskirts of Montreal, our modern facility houses a world-class chemistry laboratory. Our 45 HPLC/UPLC systems equipped with a full range of detectors, two ICPMS and two AAS, LCMS-QTof and other high technology equipment are ready to be used for analyses. In addition, our dedicated state-of-the-art microbiology laboratory can provide to our clients customary analyses, sterility, endotoxins, antibiotic testing and bioburden. Moreover, we possess two narcotic vaults (level 5 & 7) and 15,000 cubic feet of stability storage, including photostability and narcotic stability studies that meet the ICH guidelines and support special storage conditions adapted to a client's specific needs and requests.

Standards & Methodologies

Neopharm is committed to providing its clients with the highest quality in analytical (chemistry, chromatography, microbiology), consulting, stability, development and validation services. We strive to respect client timelines, as well as the accuracy and integrity of all data generated while performing tests or projects. We pride ourselves in ensuring our facilities, equipments, records and procedures are maintained in accordance with applicable regulatory and compendial requirements with respect to the Client's specifications.

All analyses are performed in compliance with cGMP requirements using methods in accordance with compendial procedures including but not limited to: USP/NF, BP, Ph. Eur, JP, CP, FCC, ACS, AOAC, AOCS, AAMI, AWWA, FDA-BAM, In-house and client supplied methods.Over the years, Neopharm has successfully developed/validated/transferred in excess of 3,000 HPLC, GC or other chemistry analytical procedures.