Value addition to our customers through our practical and logical Vision is our Mission

 

To support and assist the individual departments in the preparation of

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  • GENRAL SERVICES
  • SCOPE OF SERVICES

cGMP consultancy under one roof for design, implementation and the accreditation from USFDA, EDQM/MHRA, Australian-TGA, ANVISA, PMDA, MCC, ISO 9000, WHO GMP and other regulatory agencies.

VVM PHARMA GMP CONSULTANTS is promoted as an integral centre purely with a service intention and to become a part towards building a healthy nation.

It targets serving prospective small and medium pharma companies who aspire to upgrade their quality and documentation system conforming to both local and international regulatory standards and to get accreditation from USFDA/EDQM/MHRA/TGA/ANVISA/PMDA/ISO 9000 at an unbelievable and much economical budget.

VVM PHARMA GMP CONSULTANTS strongly believes to work within the available resources in any organisation and shall involve from the basic level and to bring to the required standards in the areas of Quality Control, Quality Assurance, Regulatory Affairs, Process Development, Plant Design of industries related to the manufacture of,

  • Active Pharmaceutical Ingredients
  • Intermediates
  • Excipients
  • Finished Dosage Forms (Solid oral, Liquid Oral, Dry Injectables, Paranterals ( SVP/LVP), Ointments, Creams

Its services shall also include other allied sectors like,

  • Packing Materials / Public Testing Laboratories
  • Vendor Audits/Vendor Development
  • Training and Evaluation
  • Preparation of DMFs/ANDA in CTD Formats, Dossiers and submission to regulatory bodies
  • Documentation specific to Industry
  • A regulatory platform in Asia-Pacific for Multinational Companies

VVM PHARMA GMP CONSULTANTS aims to be competitive and unique by undertaking more challenging assignments with time bound targets and goals to achieve. It is perhaps routed from the rich and multilevel experience gained by the promoter by working in various reputed pharma companies

  • To support and assist the individual departments in the preparation of Standard operating procedures for their day to day activities with more practical inputs and easy to follow.
  • To periodically train and update all the personnel on cGMP and maintenance of relevant documentation.
  • To support and assist in the preparation of Drug Master Files , Dossiers and other Technical documents conforming to USFDA, MCC, EDMF, TGA, ANVISA and other various international regulatory bodies.
  • To support and assist in performing Annual product quality reviews and preparation of relevant documentation.
  • To support and assist in various Validation programmes like Process validation, cleaning validation, Analytical method validation, Air system validation ,water system validation and preparation of reports conforming to international standards.
  • To support and assist in the preparation of answers to Questionnaires and other technical clarification from various customers
  • To guide and assist stability programmes as per ICH Guidelines and compilation of data.
  • To perform periodic internal Audits and submission of reports with necessary suggestions for improvement.
  • To participate and assist the company personnel during External Audits by GMP experts of other companies and regulatory agencies and preparation of compliance report..
  • To perform Vendor evaluation on company’s behalf in the selection of suppliers of Materials and preparation of relevant documentation.
  • To support and assist in handling customer complaints and preparation of relevant documentation
  • To support and assist in maintaining Good Laboratory Practices and preparation of relevant documentation.
  • To support and assist in the calibration of all analytical instruments and other measuring devices as per approved protocol and preparation of relevant documentation.
  • To support and assist in Installation Qualification, Operation Qualification and Performance Qualification of new equipments
  • To support and assist in any other related activity as required by the company from time to time.