CLINIQAL ^TM, Inc. holds comprehensive commercial liability insurance for the protection of our clients!

PRIMARY SERVICES

Quality Auditing – Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) audits to include:

• Clinical Site Audits
• Vendor Qualification Audits
• Electronic Systems Validation and Medical Software Manufacturer Audits
• Sponsor Audits
• Inspection Readiness Audits (e.g., US FDA, MHRA, EMA, PMDA)
• For Cause/Directed Investigations
• CAPA follow-up and Effectiveness Verification

QA Infrastructure Development

Training – in support of GCP and GCLP (Clinical/Medical laboratory activities)

Clinical/Medical Laboratory Accreditation Services

• We specialized in US and international College of American Pathologist (CAP) accreditation.
• Expert consulting in support of GCLP, CLIA, CAP and ISO 15189 certification/licensure.

Prequalification audits and Preparation Service – review quality systems in lieu of regulatory and/or notified body inspections/audits (e.g., US FDA, MHRA, EMA, PMDA).

SECONDARY SERVICES

Good Manufacturing Practice (GMP)

• Quality auditing
• Training
• Infrastructure development

Regulatory Affairs – regulatory document review, preparations and submissions