Business ServicesConsultingIndia Operon Strategist

Operon Strategist

Company Details

  • Operational Address : P. 511, Fifth level, Mayurtrade centre, phase - 1, Chinchwad, PUNE - 411019 MAHARASHTRA, Pune, Maharashtra, India
  • Business Type : Other
  • Location : MAHARASHTRA, India
  • Year Established : 2011
  • Main Markets : North America 50.00% Eastern Asia 40.00% South America 10.00%
  • 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 Services, Validations Of Medicaldevice Equipment And Utility, Medical Device Turn Key Consultant, Medical Device Design And Development, Project Consultant,Certification,Medical Device Approval, Primary Packaging Project Consultant, Laboratory Centers Turnkey Project Consultants, Hospital Turnkey Project Consultant, Medical Device Consultant,
  • Links : India Business Services, India Consulting, India Technology Consulting,

    • Company Introduction

    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&＃39;s, Laboratories and Hospitals. We 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&＃39;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 :
  • Website : http://www.operonstrategist.com

    • Company 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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