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
Company Details
- Employees
- 2
- Founded
- -
- Address
- Pune, Maharashtra, In
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- http://Gextol.com
- HQ
- Pune, Maharashtra
Gextol Consultancy Services (Gcs) Questions
Gextol Consultancy Services (Gcs)'s website is http://Gextol.com
Gextol Consultancy Services (Gcs)'s LinkedIn profile is https://in.linkedin.com/company/gextol-consultancy-services-gcs
Gextol Consultancy Services (Gcs) has
2 employees.
View email and phone details for 2
employees at Gextol Consultancy Services (Gcs).
Gextol Consultancy Services (Gcs)'s industry is
Medical Equipment Manufacturing
Gextol Consultancy Services (Gcs)'s top competitors are
Olympicks Medical Systems,
Divas Medic Sdn Bhd,
Endoscopex,
Best Medical Gmbh,
Sapphire Diagnocare,
Skopein,
Novelmedic,
Synergen Bio Pvt. Ltd.,
Authentic Medical Systems Pvt Ltd,
Polestar Electro Medical Services.
Gextol Consultancy Services (Gcs)'s categories are Medical Equipment Manufacturing
Gextol Consultancy Services (Gcs)'s founding year is 2022
