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Quality Assurance:
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Capabilities:
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Independent QA function at all Lambda sites |
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Spacious, secured archives facility at sites for
archival of study & related documents provided with adequate
safety measures & temperature/humidity monitoring facility |
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Well structured QA audits
at pre-defined intervals to ensure data integrity |
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Regular system audits to
facilitate continuous system improvements
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Experience:
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Handled inspections of various regulatory
authorities/competent bodies seeking their
approval/accreditation |
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Handled regulatory/sponsors queries, recommendations
through corrective/preventive actions, modifying and
implementing our systems and processes wherever required |
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Conducting internal audits
of study activities and data/reports and ensuring
compliance as indicated by acceptance of the product
dossiers (Regulatory submissions) by regulatory agencies
across the globe and granting marketing authorization
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Services:
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GCP/GLP Audits
(In-process, retrospective & system audits) |
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Handling regulatory
inspections (national & international) |
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Handling sponsor audits
for assessment of Lambda’s facilities & GCP/GLP
compliance |
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Expertise in conducting
external vendors/service providers audits, like
pathology labs, x-ray units, calibration agencies etc. |
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Management of central
archives facility at Lambda
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Why us?
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Dedicated, qualified &
well trained QA auditors |
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Teams with well defined
job responsibilities for conducting internal audits (Clinical Pharmacology & Medical Affairs,
Clinical Trials Management, Clinical Laboratory, Clinical Data Management, Bioanalytical, Pharmacovigilance Audits, Project Management & Pharmacokinetics and Biostatistics & Programming), document control and
archival activities |
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Lambda Therapeutic Research Ltd.
