Operon Strategist

Company Description

The "Operon Strategist is working towards the catalyzing and ensuring the strategic development of the clients in the areas of Regulatory approvals , Quality Assurance, Quality Control, Licensing and Marketing authorization for the Medical Devices industry, Pharmaceuticals, R and D centers, CRO's, Laboratories and Hospitals. Operon Strategist undertake turn key projects, annual regulatory contract as well as functions on the customized packages as per the need of the client. The Company is owned and supported by the renowned professional's from different fields of expertise. We owe the people who have high experience and expertise in relevant fields at the national and international level. The company has got all the talents to take up the challenging projects which require high technical expertise and experience. On basis of our long term, committed and ethical services, the international professionals and business houses are attracted to us for the business relations in terms of associates and partners

Company Information

  • Contact Person:Mr. anil Chaudhari
  • Telephone:
  • Province/State:Maharashtra
  • Operational Address:P. 511, Fifth level, Mayurtrade centre, phase - 1, Chinchwad, PUNE - 411019 MAHARASHTRA, Pune, Maharashtra, India
  • Business Type:Other
  • Year Established:2011
  • Main Products:Medical Device Turn Key Project Consultant, Pharmaceuticals Turnkey Project Consultant, Laboratory Centers Turnkey Project Consultant, Hospitals Turnkey Project Consultants, Equipment And Utility Validatio, Manufactuing Unit Design, Pharmaceutical Projects, Documentation For Medical Industry, Audit And Compliances, Plant Set Up Design, Quality Assurance,Certification And Licencing, Microbiological Ser,
  • Main Markets:North America 50.00% Eastern Asia 40.00% South Ame
  • Location:MAHARASHTRA, India
  • Website:Visit website

Product

  • Certification, Regulatory Advisory services
  • ISO certification
  • NABL Accreditation Service
  • US FDA 510 (k) clearance
  • CTD Liasoning Service
  • Countries Specific DMF /DMF Certification
  • EU GMP
  • CDSCO Certification
  • Establishment Registration and Device Listing
  • GMP Implementation
  • GMP Gap Analysis
  • GMP Primary Packaging Quality Assurance
  • QA Implementation
  • CAPA Management System
  • Change Management System
  • Medical Device Unit Design
  • Facility Plant Design
  • Facility Plant Build Up
  • Clean Room Design
  • Plant Layout Design
  • Medical Device Facility Design
  • GMDN Number Assessment
  • EU Agent Appointment
  • Audit Compliances
  • Third Party Audit
  • GMP Audit
  • Regulatory Audit Compliances
  • Regulatory Licensing
  • SOP Preparation
  • SMF Preparation
  • DMF Preparation
  • Dossier Preparation
  • Pharmaceuticals Analysis and Implementations
  • Drug Master File Preparation
  • CDSCO Strategic Services
  • Pharmaceutical cGMP
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