Regulatory Consulting
Access global & Indian regulatory pathways with confidence. We deliver end-to-end support for CDSCO (India), US FDA (510(k), IDE, De Novo, PMA), CE marking under EU MDR/IVDR, TGA Australia, Health Canada, UKCA, SFDA (Saudi Arabia), MDA (Malaysia), HSA (Singapore), COFEPRIS (Mexico), ANVISA (Brazil). From dossier preparation, technical documentation, notified/authorised body coordination, to post-market compliance- we guide you through global regulatory strategy, submission, approval and maintenance.
- CDSCO India
- USFDA approvals (510k, IDE, Denovo, PMA)
- CE Certification (EU MDR & EU IVDR)
- TGA Australia
- Health Canada
- UKCA
- SFDA
- MDA Registration
- HSA Registration
- COFEPRIS Registration
- Brazil ANVISA