We undertake the Projects of the Manufacturing set ups of the Pharmaceutical and the Medical Device industry.
Contact Details:
Operon Strategist,+91 9823283428
7, "A" Tower,
First Floor, Sagar Complex
Kasarwadi, Pune : 411034
Maharashtra India.
Phone: +91 (020)46780055
E-mail: anil@operonstrategist.com
info@operonstrategist.com
anilmchaudhari@gmail.com
Website:www.operonstrategist.com
Medical device turnkey
Medical device plant set up
Medical device Plant design
medical device plant consultant
medical device unit consultant
medical device regulatory
Medical device facility set up
Medical device design consultant
medical device unit design
medical device unit set up
Orthopedic implant plant set up
disposable turnkey project
Clean room set up
Clean room designing and set up
Clean room panel suppliers
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Pharmaceutical Plant set up
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DMF preparation
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Medical device manufacturing Setup consultant
Medical Device Manufacturing Unit Design
510k consultant
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GMP consultant
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Medical Devices
Turnkey Project
- Facility Design
- Facility built up
- Regulatory Liasoning
Regulatory
- USFDA 510 (k)
- 510 K file preparation
- File submission
- Establishment registration and device listing
- US agent appointment
- China FDA registration
- GMDN number assessment
- US agent appointment
- EU Agent appointment
Quality Assurance
- Current Good Manufacturing Practises (cGMP):GAP ANALYSIS and Implementation as per requirements of
- USFDA ( 21 CFR Part 820)
- Europe (CE requirements)
- WHO-GMP
- CDSCO (Indian FDA)
- ISO 9001 : 2008
- ISO 13485 : 2003
- Audit Compliance of
- USFDA (21 CFR Part 820)
- Europe ( CE requirements)
- WHO-GMP
- CDSCO ( Indian FDA)
- ISO 9001 : 2008
- ISO 13485 : 2003
- CAPA Management System
- Change Management System
Validation
- Equipment Validation
- Utility Validation
- Microbiological Validation
- Process Validation
- Cleaning Validation
- Analytical Method Validation
Certifications
- ISO 9001 : 2008 : Quality management System
- ISO 13485 : 2003 : Quality management system - Medical devices.
Training
- Current Good manufacturing Practises.
- Equipment And Utility Validations
- Microbiological Validation
- Cleaning Validation
- CAPA Management System
- Change Management System
- ISO 9001:2008 - Quality Management System Requirements
- ISO 13485 : 2003 - Quality Management System- Medical devices.
Third Party vendor audits
- Third Party vendor audits on behalf of Company.
Contact Us
Anil Chaudhari
| Phone: | +91 (020)46780055 |
| Mobile: | +91 9823283428 |
| Email: | anil@operonstrategist.com |
| info@operonstrategist.com | |
| anilmchaudhari@gmail.com | |
| Skype: | Operonstrategist |
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