CEO of operon strategist , Mr.Anil Chaudhari has over 25 years of experience in the healthcare industry.
The Operon Strategist 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. are our activities.
We provide Regulatory Consultant Service For ISO 9001, ISO 13485, We Successfully handled Regulatory Project For CE Marking ,USFDA, USFDA 510(k),21 CFR Part 820, FDA, GMP, ANVISA, TGA, and client audits towards GMP certification & product registration.
We Have Successfully Handled 60+projects Related to Medical Device Manufacturing Industry and 30+ projects are the Turnkey projects By including Layout Design, Clean Room Design, Facility Plant setup Design & Process validation.
Efficient and effective relationship management With the client , communication skills with ability to lead & key influencers role in regulatory affairs, regulatory compliance systems, audits and quality assurance.
Medical Device Manufacturing Industry;
Primary packaging Manufacturing Industry;
We assist medical device companies for Device registration, quality management system compliance, Audit compliance, Development of products at each phases, Technical dossier compliance and review.
Our team evaluates manufacturing operations, identifies areas for improvement and executes system compliance.