Quality Compliance

Quality audits provider

Quality Compliance

We also have a team of top-class consultants and subject matter experts in the industry and we provide following Quality Compliance related services to the Pharmaceutical companies:

  • Pre and post-inspection audits (inspection preparation and remediation).
  • Providing Quality/project support remotely as well as on-site.
  • Training on any technical topics based on the client’s need.
  • Provide the cost effective and highly qualified resources remotely to the international clients.
  • Provide the guidance to obtain the EU/ US inspection preparedness.
  • Gap assessment of the site and recommend the remediation plan.
  • Guidance/ design of QMS for continuous improvement.
  • Drafting the SOPs and other documents.
  • Set-up of Computer Systems and CSV as well as ITQA compliance Or as required by clients.

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    Audit Report Package

    Our Audit Report Package is very thorough and includes all of the following which is sufficient enough to qualify the supplier:

    • Full Audit Report.
    • Auditor’s CV.
    • Auditor’s non-conflict of interest declaration.
    • CAPA plan with evidence, as applicable.
    • Audit closure signed by Lead Auditor, with CAPA review confirmation.
    • Attachments including lists, certificates, licenses, layout etc.
    • Additional documents such as SMF, SOP index, Site presentation etc. as available.