HLC Consulting Service - Regulatory Inspection readiness， hlcconsultservices， Third Party Auditing， Qualification & Validations， Regulatory filings

Quality & Regulatory Compliance including Warning Letter Response / Post-Audit Response
Quality & Compliance Remediation including GAP analysis, Comprehensive Assessments, Risk Assessments & Quality Assessment Reviews.
Triggering of Any International Regulatory Audits
Project & Program Management in CMO, Clinical & Research Studies and Product Development & Technology Transfer
Training and Development
1. Impart cGMP, GLP, GDP, GCP, GEP training programs and developing skills for qualified internal/external auditor.
CSV/Software/IT Compliance
1. QMS solution through GAMP5 / Software Commissioning, Qualification & Validations.
CSV/Software/IT Compliance
1. 510 (k) FDA submissions, Devices for ISO 13485-2016 Compliance / FDA 21 CFR part 820 – QSR Compliance / Combination devices – 21CFR Part 4 Compliance / MDR Compliance solutions.
Data Integrity Solutions in Pharmaceutical laboratories
Panel Advice for TFDA/US FDA-483/MHRA/TGA/EU audit response.