Compliance Audit Partners
Consulting firm providing global GxP quality assurance and auditing services for pharmaceutical, biotechnology and medical device organizations. Core activities include investigator site and vendor audits, regulatory inspection preparation, document and TMF quality control, computer systems validation, CAPA management, and remote audit delivery. The firm also offers CRO-related services through an affiliated entity.
Industries
Nr. of Employees
small (1-50)
Compliance Audit Partners
Products
Global Auditing Services
Provides auditing services to assess compliance with regulatory and industry standards across global operations.
Regulatory Inspection Preparation
Assists organizations in preparing for regulatory inspections by reviewing documentation and processes to ensure readiness.
Document Audit Services
Reviews and audits organizational documents to verify compliance with regulatory and quality standards.
Global Auditing Services
Provides auditing services to assess compliance with regulatory and industry standards across global operations.
Regulatory Inspection Preparation
Assists organizations in preparing for regulatory inspections by reviewing documentation and processes to ensure readiness.
Document Audit Services
Reviews and audits organizational documents to verify compliance with regulatory and quality standards.
Services
Investigator site audits, vendor and CRO audits, database and TMF audits, Part 11 assessments, REMS and PV audits, GLP/GMP audits.
Mock inspections, pre-inspection preparation, onsite inspection support, submission document QC and QA, quality strategy development.
Quality control and review of study documents, regulatory submissions and trial master file contents.
Validation and assessment of computerized systems to support compliance with electronic records and signatures requirements.
CAPA development and management, and on-site or remote QA support services.
Develop and deliver training on QA and GxP topics.
Investigator site audits, vendor and CRO audits, database and TMF audits, Part 11 assessments, REMS and PV audits, GLP/GMP audits.
Mock inspections, pre-inspection preparation, onsite inspection support, submission document QC and QA, quality strategy development.
Quality control and review of study documents, regulatory submissions and trial master file contents.
Validation and assessment of computerized systems to support compliance with electronic records and signatures requirements.
CAPA development and management, and on-site or remote QA support services.
Develop and deliver training on QA and GxP topics.
Expertise Areas
- GxP quality assurance
- Clinical trial auditing
- Regulatory inspection readiness
- TMF management and QC
Key Technologies
- Electronic data capture (EDC) systems
- Electronic Trial Master File (eTMF) systems
- Interactive response systems (IVRS/IRT)
- Remote audit platforms and virtual document access
News & Updates
Announcement of a new managing partner and expansion of services including offering CRO services via an affiliated subsidiary, and expanded global footprint.
Company communication describing continuation of QA and auditing services during the COVID-19 pandemic, recommendations on remote audits, and examples of remote audit types performed.
Summary referencing FDA guidance on conducting clinical trials during the COVID-19 pandemic and considerations for trial integrity and participant safety.
Announcement of a new managing partner and expansion of services including offering CRO services via an affiliated subsidiary, and expanded global footprint.
Company communication describing continuation of QA and auditing services during the COVID-19 pandemic, recommendations on remote audits, and examples of remote audit types performed.
Summary referencing FDA guidance on conducting clinical trials during the COVID-19 pandemic and considerations for trial integrity and participant safety.