Your needs : to verify that your APIs comply with relevant standards and regulations
APIs, or active pharmaceutical ingredients, are substances contained in drugs that are responsible for the health benefits they bring to the patient.
Subject to numerous international regulations, including ICH Q7, the quality and safety of APIs is a primary requirement for any pharmaceutical manufacturer to get their product to market.
In light of this, the use of a specialized inspection laboratory guarantees compliance with standards, efficiency and safety of your pharmaceutical products.
Our solution : to provide you with our methods and our technical facilities to be able to characterize your active pharmaceutical ingredients
For 30 years, the laboratory has been assisting manufacturers in the pharmaceutical industry with analysis, inspections and the development of reliable and compliant products.
From analysis to project management, FILAB provides the following services :
- API analysis using GC-MS, NMR or LC-MSMS
- Inspections of finished products
- API compatibility and stability testing
- Detection of elemental impurities in pharmaceutical products in accordance with USP 233
- Development of new analytical procedures for determining API contents in accordance with relevant standards
- Deformulation/Reverse engineering of finished products
FILAB provides direct technical support to answer all your questions and to guarantee a quick turnaround of your requests.
