ClinAudits.com
Title
ClinAudits - Auditing, Consulting and Training Services Specializing in GCP Audits - GLP Audits - GMP Audits
Description
Excerpted from the website description:
- ClinAudits is an independent, 3rd party, niche provider of GXP (GCP, GMP, GLP, GTP) compliance, auditing and consulting services for the pharmaceutical, medical device, biotechnology and tissue engineering industries. In addition, ClinAudits services medical academic institutions. These services are geared toward compliance to U.S. Food and Drug Administration (FDA) guidelines, Drug Enforcement Agency (DEA) laws, International Congress on Harmonization (ICH) requirements, client and vendor SOP’s and other domestic, International and local governmental requirements. ClinAudits specializes in conducting GCP audits, GLP audits, GMP audits, and GTP audits by providing low-cost, quality remediation solutions.
Languages
English
Additional Information
AUDITING SERVICES include:
GCP
- Auditing to comply with FDA regulations, ICH Guidelines, and local governmental regulatory guidelines or company-specific SOPs and guidelines
- Investigator Site Audits
- Audits of Contract Research Organizations (Pre-qualification and Post Capability) and CRO managed studies
- Pre-placement assessment of study sites
- Central and Specialty Laboratory Audits
- Clinical Trial Supply Audits/Drug Depot
- IVRS Audits
- Final Study Report Audits
- Adverse Event Reporting System Audits/Drug Safety/Pharmacovigilance
- Clinical Pharmacology and Phase I Units
- Document Archiving, Trial Master File or Records Management Systems
- Monitor Training/Monitoring Department
- Computer Validation Systems
- Gene Therapy Audits
- Institutional Review Board (IRB)/EC Audits
- Patient Registries
- Database Audits
- Electronic Submissions Audits
- Sponsor/Monitor Process/System Audits
- Mock-FDA or Other Governmental Authority Audits
- Remediation
- SOP Documentation Systems
- 21 CFR Compliance
- CAPA review, reconciliation and close-out
GLP
- Audits of Safety or Specialty Laboratories
- Pre-clinical Laboratories
- Laboratories associated with Manufacturing Facilities
- Mock FDA or Other Governmental Authority Audits
- Computer Validation
- Facility Design
- Qualification of GLP Facilities
- SOP development and documentation systems
GMP
- Setup/Review Stability Programs and Data
- Process/Equipment Validation
- Vendor Facilities (API, Bulk, and Commercial)
- Batch Record Review and QC Checking
- Computer Validation
- Facility Design
- Qualification of GMP Facilities
- Mock FDA or Other Governmental Authority Audits
- SOP Development/Documentation Systems
CONSULTING SERVICES include:
- Train QA and clinical research personnel at your facility or the study site
- Provide QA staff to come to your facility for internal projects
- Develop/review/revise Standard Operating Procedures
- Develop or review FDA IND safety updates
- Medical Writing
- Design and implement clinical project workflow/timelines (project management)
- Regulatory Affairs submissions including preparing filings for IND, PLA, NDA, BLA, IDE, PMA, and 510k
- Post submission inquiries, updates, and reviews
- Review of Serious Adverse Event Reporting, labeling, packaging, and marketing materials
External Links
- Main Website: ClinAudits
- Twitter Profile for ClinAudits
- LinkedIn Profile for ClinAudits
- Facebook Profile for ClinAudits
