|Antrix offers full range of expert
regulatory affairs and quality assurance consulting services
to the IVD, Medical Device, Pharmaceutical, and Biotech
Industries worldwide. Setup ISO 13485, CLIA and CAP Quality
Management System and Certification.
Antrix also offers full range of services for Mobile Medical Apps adhering to FDA, EU and IEC 62304 - Medical Software Lifecycle Process standards.
Using our services you can achieve potential productivity gains and cost savings of up to 90%. We can provide you with complete return on investment (ROI) details for your projects.
Avoid regulatory warnings, violations and fines by using regulatory compliant pre-packaged products and services:
- Pre-packaged regulatory marketing templates for medicinal products, drugs (CTD - IND, NDA, ANDA), medical devices (IDE, 510(k), PMA, EU), and powerful document authoring tool facilitates the preparation of submission ready documents for the life science industry.
- Pre-market pathways and post market requirements for Mobile Medical Apps, In Vitro Diagnostic Multivariate Index Assays (IVDMIA) for both expression & genotyping molecular diagnostic markers.
- Pre-packaged design control quality system regulations compliant new product development templates helps jumpstart the product development and validation effort.
- Pre-packaged design control compliant verification and validation suites for popular software's and manufacturing process helps cut down the cost and time to validate.
- Pre-packaged QSR procedures reduces the time and cost to implement a fully functional quality management system in a company.
Vibrant, Stryker, C8 MediSensors, Ekso Bionics, MDS Pharma, Oratech, Abbott Diagnostics, Ligand Pharmaceuticals, Oracle/Sun Microsystems, Motorola, Star Sight Telecast, Vicor Systems, Ehealthworld, Epoolandspa, Flexwatch, Unisoft, Nicolet Medical Instruments.