About
Operon Strategist a regulatory consultant, provides services to medical device, IVD's and primary packaging material manufacturers.
Our team of experts handle the regulatory and documentation review for Medical Device Manufacturers and Contract Manufacturers. We provide turnkey solutions to setup world class Manufacturing facility, System Implementation, Training, Licensing, Regulatory approvals and Certifications. Our global presence caters to clients from around the globe & includes small start-ups to world’s renowned medical device manufacturers. As a trusted partner to our clients, we strive to provide services within b...
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Services
Manufacturing Plant Layout Design
Process validation
medical device design and development
Drug-Device Combination
21 CFR part 210 and 211
FDA 510(k)
Clean Room Design
21 CFR part 820
CE Marking
QMS and Certification
USFDA
Post-marketing support
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Contact
Current Hours
- Sun CLOSED
- Mon 10:00 AM - 6:30 PM
- Tue 10:00 AM - 6:30 PM
- Wed 10:00 AM - 6:30 PM
- Thu 10:00 AM - 6:30 PM
- Fri 10:00 AM - 6:30 PM
- Sat CLOSED
-
Tue 10:00 AM - 6:30 PMOPEN NOW
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Detailed Information
- Location TypeBranch
- Opening Dateunknown
- Annual Revenue Estimateunknown
- SIC Code show
- Employeesunknown
- Contactsshow
- CEO Anil Chaudhari
- Email [email protected]