Gextol Consultancy Services Gcs

We offer comprehensive pharmaceutical and medical devices consulting & training. We have teamed together with ex notified body auditors, lead auditors, regulatory experts and medical writers to provide consultancy services to your industry. Gextol Consultancy Services provide cost effective services as per client’s requirements which are tailored for customer needs. We provide services in Regulatory and Quality domain, Our list of regulatory services to name a few are: CDSCO Licensing consultancy service (Voluntary Registration, Manufacturing & Import Licence). Tech file gap analysis DHF remediation Brexit transition QMS Clinical/Performance Evaluation Technical documentation preparation and management, including General Safety and Performance Requirements (GSPR) Instructions for Use (IFU) and labelling updates/review Creation of a Unique Device Identification (UDI) system including Basic UDI-DI Post-Market Surveillance (PMS): Vigilance reporting,complaint handling, PMCF, PSUR. Quality Services to name a few are: ISO 13485 certification USFDA Part 820 CE Marking 510K Submission Equipment Qualification and Validation Auditing solutions QMS to MDR transition If you require support in tech file remediation, we will be happy to support your needs at a cost-effective rate. To set up a free appointment please Whatsapp +91-9359657548