A importância da Inteligência Regulatória para sua empresaA Inteligência Regulatória é um recurso que fornece informações estratégicas no momento de tomar decisões eficientes no contexto regulatório. É uma das visões mais importantes para sua empresa que necessita cumprir exigências governamentais.Um processo regulatório eficaz utiliza a inteligência [...]
The importance of Regulatory Intelligence for your companies Regulatory Intelligence is a resource that provides strategic information when making efficient decisions in the regulatory context. It is one of the most important visions for your company that needs to comply with government requirements. An effective [...]
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 [...]
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 [...]
Computer Systems Validation The Computerized 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 [...]
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 [...]
How does CE Marking work? 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 [...]
Risk Management and Usability: Ensuring Safety and Efficacy in Medical Devices Risk management and usability are essential processes for the safety and effectiveness of medical devices. They aim to identify, assess, and mitigate risks associated with product use while ensuring the product is easy and [...]
Passarini International Certifications and Licenses Exporting is one of the best ways for companies to grow and achieve sustainability. Passarini Group, boasts of extensive experience in CE marking services having successfully facilitated one of the first CE certifications of Brazilian medical equipment in [...]
What is ANVISA? ANVISA, abbreviated from Portuguese “Agencia Nacional de Vigilancia Sanitaria,” is the food and drug regulatory agency in Brazil. ANVISA Registration has been a requirement for businesses operating in Brazil since the regulator was created in 1999. ANVISA Regulations aim to protect and [...]
