At Medisol Laboratories, we conduct a wide range of tests to assist in the chemistry, manufacturing, and controls (CMC) processes for pharmaceutical and biopharmaceutical products, covering every stage from drug development to commercialization and life-cycle management.
Our services encompass comprehensive support for your internal quality procedures, including sterile (USP 71) testing carried out in a cleanroom or isolator, particulate (USP <787> and USP <788>) testing utilizing various methodologies, bacterial endotoxin testing, filter validations, container closure integrity testing (CCIT), and USP compendial testing. Regardless of whether the product undergoes terminal sterilization using gamma, e-beam, or ethylene oxide (EO), our experts possess the knowledge and proficiency to handle these tests effectively.
Moreover, we offer analytical services such as stability studies, stress studies, identification and characterization of organic impurities, and testing for extractables and leachables (E&L) as well as elemental impurities (USP <232> and USP <233>).
Additionally, we provide quality control assessments for active pharmaceutical ingredients (APIs), starting materials, intermediates, finished products, impurities, and degradation products.
Please refer to the fact sheets below to explore the extensive range of tests we offer for pharmaceutical and biopharmaceutical products:
- Microbiological Testing for Pharmaceutical & Biopharmaceutical Products
- Raw Materials & Container Closure Integrity Testing for Pharmaceutical & Biopharmaceutical Products
- Residual Solvents & Elemental Impurities Testing for Pharmaceutical & Biopharmaceutical Products
- Stability Management for Pharmaceutical and Biopharmaceutical Products
- Sterility Testing of Parenteral & Ophthalmic Drug Products to Support Your Sterility Assurance Program.
In addition, we can assist in environmental and water system testing for your facility and validate cleaning processes within the cleanroom. Collaborating with our sister company Sterigenics, we can explore alternative options to aseptic processing through various terminal sterilization methods.
With a longstanding history of partnerships with pharmaceutical and biopharmaceutical companies, Medisol Laboratories boasts a team of over 700 scientists, technicians, and service specialists conducting the aforementioned tests in multiple laboratories worldwide. With our decades of expertise, we guarantee the quality of our results and the strength of our customer relationships.