ClinAudits, LLC, provides quality assurance and regulatory compliance auditing and regulatory consulting services to the pharmaceutical, biotechnology, medical device and biological industries. We serve your needs for compliance with GCP, GMP, and GLP. While specializing in GXP audits, ClinAudits’ services extend to Phase I-IV clinical studies of pharmaceuticals, as well as serving the needs of clients developing medical devices, biotechnology, biologicals, gene therapy agents and Rx to OTC drugs.
Since 1994, ClinAudits has delivered these services both domestically and internationally including locations in the North and South America, Europe, Asia (India, Russia, China, Taiwan), South Africa and Australia/New Zealand. ClinAudits has a team of auditors, located in the U.S., Canada, Europe, Asia, India, South America, and Australia, with extensive experience in clinical research and drug development. This experience encompasses a broad range of disciplines including, but not limited to: Oncology, Infectious Diseases, Respiratory Diseases, Central Nervous System (CNS), and Dermatology.
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 · Training · REMS audits · Quality Risk Management · Co-monitoring as sponsor oversight
· 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 · Final study reports ·Vendor and supplier qualification audits · Training
· GMP: Audits of: 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 · Training
CONSULTING SERVICES can serve your needs to:
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 ·
Project management Design and implement clinical project workflow/timelines · 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
Personalized, professional consulting for regulatory compliance with domestic and international standards can be provided for companies that are:
· Growing · Outsourcing · Downsizing
From Preclinical to Phase IV and then commercialization, ClinAudits operates strictly within FDA and other governmental authority GXP guidelines/regulations. The complete portfolio of services is geared toward complying with FDA guidelines/regulations, Drug Enforcement Agency (DEA) laws, EMEA, International Congress on Harmonization (ICH) requirements, client and vendor SOPs and other domestic, international and local governmental requirements. Our competitive advantage lies in delivering high quality service, being responsive to each client’s specific needs providing added-value solutions that are timely and cost-effective.. If you seek to capitalize on your core competency, improve your return on investment, increase your flexibility, and reduce your risk, our experienced consultants can provide you with compliance services. We can ensure that your critical compliance activities are completed on time and in a resource-effective manner.
Bioanalytical Data Audits/Laboratory & Validation Evaluation, Computer System Validation, Consulting, Contract Auditing, GCP Compliance, GLP Compliance, GMP Compliance, Quality Assurance/Control, Standard Operating Procedures, Training