Case Study 69: Registration of Special 510(k) for Medical Gloves with FDA-USA
US Medical Device company that manufactures and sales No-Sterile, Blue Powder-free Nitrile Exam Gloves that are used for medical examination, wanted to commercialize in USA a new model of same gloves with a different color (purple), and was looking for regulatory affairs professional who can give them guidance on how to register the new model with FDA.
Case Study 40: Regulatory Support for ANDA Submission for the US FDA
The Client is a Hong Kong in a process of developing a generic product needed support for ANDA submission along with US local agent who can respond to USFDA queries.
Case Study 39: Regulatory Support for eCTD Publishing for Biologics
The Client is a US based biotechnology company with transfusion dependent products for Thalassemia.
Case Study 23: Registration of a Class II Medical Device in Canada and USA
The Client had developed a combination device intended for temporary protection and restoration of bladder cavity that is used in combination with hyaluronic acid.
Case Study 31 : China Regulatory Intelligence for US Based Pharmaceutical Company
Client was exploring possibilities to register new drugs in China and wanted to understand comprehensive landscape for new drug registration,
Case Study 29 : Quality Audit and Preassessment before CFDA Inspection for a European CMO
The Client had network of 10+ manufacturing sites in 5 European locations with several development and distribution centers.