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Auditing and Validation Services for FDA Regulated Industry
 
 

Good Clinical Practice Audits

The Auditing Group, Inc. (TAG) has extensive experience assisting clients in the pharmaceutical, biotechnology, and medical device industries in all phases of Clinical Practices from Auditing to Training.

US FDA - WHO - EMeA - GMP - GLP - GCP

With a world-wide exposure, TAG has Auditors available 8 hours from any location in the world. TAG has conducted audits throughout the US, Europe (East and West), China, Asia, Canada, Mexico, South America (Chile, Argentina, and Brazil), and India.

From Feasibility, Phase I through IV, and then commercialization, The Auditing Group, Inc. has the expertise and background to support your projects.

TAG operates within the regulations and guidelines set forth by the FDA and other governmental authorities.

Audit Services for;

  • Clinical Processes, Procedures and Practices - Domestic and International Clinical Research Trial Audits - established expertise in Good Clinical Practices (GCP) auditing to comply with FDA/EMEA regulations
  • Contract Research Organization Audits - expertise in auditing CROs for sponsor's pre-qualification consideration and post-capability CRO study management/ CRO managed studies
  • Case Report Form Development and Review
  • Laboratories – General and Specialty Clinical, Non-Clinical and GMP Labs - Central/Specialty Laboratory Audits - tracking clinical trial laboratory specimens through the laboratory environment to check for compliance to GCP
  • Investigators and Investigational Sites
  • Monitoring Processes and Procedures
  • JCAHO Hospital Audits in support of Clinical Trials
  • Manufacturing for Drug and Device Supplies
  • Clinical Data Management and Bio-Statistics Software Development for Clinical Systems – 21 CFR Part 11/Annex 11 Compliance
  • Validation, Qualification and Verification Processes, Practices and Procedures
  • International Congress on Harmonization (ICH) Guidelines, specific company SOPs/guidelines and local governmental regulations/guidelines.
  • Clinical Trial Supply/Drug Depot Audits - auditing all aspects of clinical trial supplies in accordance with FDA/EMEA, GMP, GCP and ICH regulations/ guidelines.
  • Institutional Review Board Audits/Ethical Committee - perform audits of IRB’s (commercial, academic, private and hospital) and EC’s in accordance with FDA/ OPHR guidelines/regulations and other international, local regulations/guidelines.
  • Audits of Final Study Reports/NDA submissions/Safety Reports/IND updates- audits of database in comparison to reports/ submissions to FDA or other governmental authorities
  • Adverse Event Reporting System/Pharmacovigilance Audits - process audit of AERS, SAES, IND Safety report procedures within a country or between countries/ subsidiaries.
  • Computer Systems Validation Audits- process audit of software and hardware for GCP, GMP or GLP settings to guarantee security and consistency of data.
  • System/Process Audits, e.g., Mock-FDA audits, electronic submission audits, clinical operations and monitoring, data entry and data management, biostatistical, and medical writing departments.

 


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