Personal Information
Organization / Workplace
Pune Area, India India
Occupation
CEO & Founder at Operon Strategist | Medical Device Regulatory Consultant | Primary Packaging Regulatory Consultant
Website
https://www.operonstrategist.com
About
The company is working towards catalyzing the Strategic Development of the Clients in the regulatory, quality assurance, manufacturing process development, product designs for the medical devices industries, Pharmaceuticals, R and D centers, Food industry and the Laboratories.
The strategic development steps and stages include but not limited to the Turnkey projects for set ups, Equipment and utilities validations, Process validations, Obtaining the regulatory approvals like EUGMP, MHRA, USFDA, 510 (k), Establishment registration and Device Listing, CDSCO etc. Gap analysis, Registration of the products in countries, Obtaining the credentials like ISO 9001,ISO 13485 and obtaining CE. etc....
Contact Details
Tags
medical device consulting
medical devices
21 cfr part 820
fda
quality system regulation
medical device
medical device turnkey project consultant
fda 510(k)
manufacturing plant layout design
design control
iso 15378 certification
primary packaging turnkey project consultant
cdsco guidelines
primary packaging
layout design
fda consultant
fda qsr
fda qsr requirements
iso 13485 certification
qsr compliance
fda approval process
medical device certifications
21 cfr part 210 and 211
drug master file
ce marking certification
regulatory guidance
qsr medical device
medical device certification
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iso 14971
product layout design
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qms certification
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iso 14644
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clean room design consultant
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iso 14644-1 cleanroom standards
iso 14644-2015
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quality management system
turnkey project consultant
primary packaging material
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capa management
what is capa
corrective and preventive action
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combination products
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21 cfr 820.30
iso 13485 consulting
iso 13485
regulatory consultant
fda 21 cfr part 820
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21 cfr 210 and 211
21 cfr part 210
21 cfr part 211
pharmaceutical
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