Regulatory management
To ensure reliable supply of our products that fully meet the requirements of the target markets, we create and maintain highest quality authorization dossier. We have gained extensive experience in the authorization of food enzymes and additives in the European Union, the USA, and other regions. By submitting Type-II Drug Master Files for our products, we support our customers in the pharmaceutical sector by reducing their regulatory challenges during development and authorization processes. We also have solid expertise regarding compliance with REACh and TSCA requirements.
At c-LEcta we constantly monitor current and future regulatory requirements and trends. As a member of the AMFEP (Association of Manufacturers and Formulators of Enzyme Products), we adhere to the sector’s commitment to maintain the strictest quality and safety standards. As a company with a robust scientific and technological background, we support several industry associations in their initiatives to communicate and promote the role of biotechnology in society.
