FDA Approval With Passarini What is FDA Approval? When a product is termed as FDA approved in the US, it means that data on the product’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and [...]
What is FDA registration? FDA stands for the Food and Drug Administration, a government agency responsible for the safety of food, dietary supplements, human drugs, vaccines, blood products, and other biologicals, medical devices, radiation-emitting electronics, cosmetics, veterinarian products and tobacco products being sold or manufactured in the United States. [...]
CE Marking services: What is CE Certification? CE Marking has contributed to the free circulation of products in the European Union (EU) market. At the same time, it guarantees authorities and consumers that the products comply with the essential requirements in terms of safety and health protection. In fact, [...]
Computer Systems Validation The Computer Systems Validation is a documental process that has as purpose to protect the integrity of the related data to the automated industrial production, guaranteeing a complete traceability of information assuring the compliance of the standards and requirements of the main [...]
ANVISA Food Registration For commercialization throughout the national territory, foods must be registered or must have their manufacturing communication formalized with the Sanitary Surveillance. The categories that require registration are: New foods and new ingredients (Resolution no. 16/1999 and Resolution no. 17/1999) Foods with functional and/or health [...]
How to register your products on MAPA? Passarini Group will lead you to an assertive process that will help your company save time when register with MAPA - Ministry of Agriculture, Livestock and Supply. AREA: WINES AND DRINKS All establishments, producers, standardizers, bottlers, wholesalers, exporters [...]
In Company Coaching Training is a process dedicated to the acquisition of new tools, concepts, techniques and skills related to a specific job position of the professional, aiming to increase their performance. In company is a type of training focusing to attend the specifics needs [...]
Process Validation The Process Validation, despite being requested in the Brazilian pharmaceutical industries since the end of 90’s, it still causes controversy and questioning about the correct way of its execution and the conduction of the study. Since is about an extremely careful study and [...]
European Representation CE Marking contributes to the free circulation of products in the European Union market (EU). Simultaneously, guarantees to the authorities and consumers that the products respect the essentials security and health protection requirements. In fact, the CE Marking symbolizes the conformity with all [...]
Optimization of the administrative and production process One of the main problems in the Brazilian industry is the low production, employing a number more than necessary of collaborators, linked with the space problems, high rate of stock or lack of merchandise to delivery. All situations [...]