Personal Information
Organization / Workplace
Pune Area, India India
Occupation
CEO & Founder at Operon Strategist | Medical Device Regulatory Consultant | Primary Packaging Regulatory Consultant
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....
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