Cibely Andrade

In charge of Project Management of products in development and launchings (NPI).

Responsible for managing the whole process of new product development (Rx, OTC and Food suplement), regarding the product formulation, analytical methods and technical data for registration of the new products according to ANVISA's regulation. Responsible for keep updated all Sanitary license and GMP's certificate for the site operation. In charge of registration dossies's review and regulatory support to business development.

Responsible for managing the whole process of new product development (Rx, OTC and Food suplement), regarding the product formulation, analytical methods and technical data for registration of the new products according to ANVISA's regulation.

Responsible for coordinating activities performed by ​​analytical and formulation development areas. Participation in Operational Excellence and Leadership Teams, thus being directly involved in projects to improve processes of the company. Responsible for the implementation of new production processes to industrial scale. Technical support to Sales, Marketing, Product Registration and Quality Assurance. Direct contact with customers throughout the period of product development and after launch, and with suppliers of raw materials and equipment needed to product development.

Responsible for development of new products in softgel capsules. Preparation of protocols and reports of Stability Studies of finished products, according to standards of the ICH and ANVISA requirements. Preparation of technical documentation (MBRs to pilot batches and SOPs relating to R&D department). Accompaniments of the first three batches in industrial scale and assistance to manufacture in Trouble Shooting. Preparation of Technical Dossiers for registration of new products.

Plasmodium falciparum: ultrastructural study of changes caused by inhibition of N-glycosylation