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Chemicals and Pharmaceuticals |
Focus on competitiveness With its expertise in industrial process engineering, AKKA Technologies works with its clients throughout all phases of their projects, in compliance with the regulatory requirements in force. It can provide appropriate solutions thanks to the know-how of its teams in a wide range of areas: research and development, client and contractor assistance, assistance with the MA dossier and regulatory affairs, quality assurance support, qualification, validation, conformity, regulations, testing and start-up, reliability improvement, optimisation and safety studies. Work is certified under MASE (industrial health and safety and environmental improvement) and UIC (in relation to chemical products).Stability studiesAKKA Technologies has conducted stability studies associated with the submission of NDA and SNDA dossiers for new products to the FDA. In the context of this project, AKKA Technologies had to evaluate the resources for conducting the analytical tests, select the sub-contractor laboratories (CRO) and manage contract signature. The Group took charge of drafting the stability reports and managing the sampling in co-ordination with the manufacturing, packaging and logistics teams, plus the study follow-up and preparation of the data, in order ultimately to be able to draft and submit a final report to the US regulatory authorities. |