CPL develops, manufactures, packages, and tests non-sterile liquid and semi-solid pharmaceutical products. We are solely focused on these dosage forms, and it’s this focus that has earned us our reputation as an industry leader, perfecting our capabilities in each of these areas.
Our facilities are registered with the U.S. FDA, Health Canada, and have been inspected by the Japanese Health Authority. There is also a Mutual Recognition Agreement between Canada and the European Union and Australia that allows products to be easily released to those regions. These and other international agencies routinely inspect our facilities through GMP or Pre-Approval Inspections, and our compliance team regularly hosts audits with current and prospective customers.
Product Development.
Our product development team consists of 35 people with over 400 collective years of formulation development and analytical experience combined. This team strives to find the balance between scientific rigor and short, efficient timelines.
Commercial manufacturing.
Our commercial manufacturing operations provide flexibility to meet various product needs, while providing award-winning customer service along the way.
Regulatory Affairs Support
We specialize in providing comprehensive regulatory affairs services tailored to the unique requirements of the FDA and Health Canada for pharmaceutical companies marketing their products in the USA and Canada.
Elemental Impurities Testing.
CPL offers elemental impurities testing services to current customers with development and/or commercial manufacturing programs and as a fee-for-service for companies who require testing. With state-of-the-art ICP-MS equipment and world-class analysts, CPL is capable of quantifying elements at the parts-per-billion level in compliance with USP <232> and <233>, EP, and ICH Q3D guidelines.
Skin Testing Services.
CPL’s Skin Lab offers, in vitro release testing (IVRT), in vitro permeation testing (IVPT), and mass balance distribution analysis (MBDA) services in compliance with SUPAC-SS, USP <1724>, and USP <1090> using the foremost technology in our GMP-certified environment.