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Our services

The Passarini Regulatory Affairs offers a range of regulatory services, besides the practical solutions to transpose the regulatory barrier in countries like Brazil, Argentina, Colombia, Ecuador, Mexico, Peru, USA and European Community.

We dispose a technical and legal knowledge equalized to the correct interpretation of the standards and legal requirements. Besides, we elaborate specifics reports about the correct interpretation of the health standards. Our communication channel allows a better comprehension about the administrative procedures. We assure the security of the documents and information of our clients.


Specializing in innovative study designs for clinical trials, literature reviews and real-world evidence, we offer complete services and functional service delivery solutions.


FDA Approval With Passarini What is FDA Approval? When a product is termed [...]


CE Marking services: What is CE Certification? CE Marking has contributed to the free circulation of products [...]


Computer Systems Validation The Computer Systems Validation is a documental process that has [...]


ANVISA Food Registration For commercialization throughout the national territory, foods must be registered [...]


How to register your products on MAPA? Passarini Group will lead you to [...]


In Company Coaching Training is a process dedicated to the acquisition of new [...]


Process Validation The Process Validation, despite being requested in the Brazilian pharmaceutical industries [...]


European Representation CE Marking contributes to the free circulation of products in the [...]


Risk Management and Usability Process The Risk Management and Usability Process is a [...]


CE Certification and FDA Registration with Passarini Passarini International Licenses and Certification Exporting [...]


What is ANVISA? ANVISA, abbreviated from Portuguese “Agencia Nacional de Vigilancia Sanitaria,” is [...]


ANATEL Certification Lately, manufacturers and distributors of equipment to the telecommunication sector encountered [...]


What is INMETRO certification? INMETRO is a Brazilian national body responsible for accrediting [...]


Quality System and Another Informations Implantation and maintenance of the systems ISO 9001, [...]


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