- Desenvolvimento de Estratégias Regulatórias
- Preparação da documentação de submissão
- Comunicação com órgãos certificadores e autoridades competentes
- Estratégia e apoio regulatório durante o projeto e desenvolvimento
- Compilação de arquivos de gerenciamento de risco
- Compilação do arquivo de usabilidade
- Gestão profissional de projetos
- Monitoria e gerenciamento de testes de produtos
- Avaliação de risco biológico (GAP Analysis)
- Planejamento de atividades de avaliação Biológica
- Avaliação toxicológica
- Monitoria de estudos
- Elaboração do relatório de avaliação biológica
- Definição de estratégia clínica
- Compilação do plano de avaliação clínica
- Pesquisa de literatura
- Elaboração do relatório de avaliação clínica
- Planejamento estratégico de ensaios clínicos e acompanhamento clínico pós comercialização
I would like to personally thank you for your dedication and professional service. It’s the perfect solution for our business.
GWA Instruments – USA
We’re satisfied with Sobel Consultancy’s regulatory services and support for our company because they tirelessly execute projects while taking all regulatory checkpoints into account to make sure that almost all activities are carried out ethical manner while achieving the maximum compliances and transparency, which is desired in all projects. Sobel Consultancy managed the entire project properly and delivered within the specified timelines, and we received permissions for our IVDs for the Brazilian market in a timely manner.
MDS – Singapur
Sobel Consultancy was hired for a medical device registration project for one of our exported goods, and we secured the registration certificate well ahead of the company’s promised deadlines. The entire project was completed on time, professionally, and within our comfort zone. We are quite pleased with Sobel Consultancy’s entire performance and will happily suggest their services to anyone.
Medulha Surgical – Mexico
Thank you for all of your hard work and dedication. I’d want to highlight your work from the last weeks. Overall, the project result was fantastic, especially with all of the valuable tips and tricks. All of our previous supplier wouldn’t be able to handle such regulatory project with that complexity and quick turnover. Thanks!
TMX Medical – USA
As a client we have experienced a very friendly target oriented service with fast solutions. Looking very much forward to further projects.
AndraTec – Germany