Quality Assurance
- Capabilities
- Experience
- Services
- Why us?
Quality Assurance:
 
bullet Capabilities:
 
bullet Independent QA function at all Lambda sites
bullet Spacious, secured archives facility at sites for archival of study & related documents provided with adequate safety measures & temperature/humidity monitoring facility
bullet Well structured QA audits at pre-defined intervals to ensure data integrity
bullet Regular system audits to facilitate continuous system improvements
 
bullet Experience:
 
bullet Handled inspections of various regulatory authorities/competent bodies seeking their approval/accreditation
bullet Handled regulatory/sponsors queries, recommendations through corrective/preventive actions, modifying and implementing our systems and processes wherever required
bullet 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
 
bullet Services:
 
bullet GCP/GLP Audits (In-process, retrospective & system audits)
bullet Handling regulatory inspections (national & international)
bullet Handling sponsor audits for assessment of Lambda’s facilities & GCP/GLP compliance
bullet Expertise in conducting external vendors/service providers audits, like pathology labs, x-ray units, calibration agencies etc.
bullet Management of central archives facility at Lambda
 
bullet Why us?
 
bullet Dedicated, qualified & well trained QA auditors
bullet 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

 

Lambda Therapeutic Research Ltd.
A CRO for Clinical Research, Clinical Trials, Medical Writing, Bioanalytical, Bioequivalence and Pharmacovigilance services.
India (Ahmedabad - Mumbai), Poland (Warsaw), USA