Clinical Quality and Compliance

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Stay Audit-Ready by Optimizing Quality Across Clinical Development and Regulatory Functions

Enterprise Quality is of paramount importance to account for conducting ethical research, ensuring patient safety, and continuously meeting regulatory compliance requirements.  Techsol has a well-established quality management system with stringent policies and procedures that governs all GxP related business functions.

We strictly adhere to the core principles of ICH-GCP and other applicable regulatory guidelines such as the Good Manufacturing Practices (GMP), Good Documentation (GDP),  Good Laboratory Practices (GLP) and Good Automation Manufacturing Practices (GAMP) for delivering all our clinical development services.

How We Help Clients

We have been a long-term compliance enablement partner for several multi-national companies. Its our passion to enable our clients to plan, prepare and stay audit-ready for any type of regulatory audit. With our broad experience across global regulations, we conduct the following types of audits for clients:

  • GCP Audits/Investigator Site Audits
  • Phase I Facility Audits
  • Central Laboratory audits
  • BA/BE audits
  • Archival Audits
  • Data Management audits & EDC audits,
  • CSR Audits
  • TMF Audits
  • Safety Database Audits
  • QMS Audits
  • Vendor Audits
  • Computer System Validations/21 CFR Part 11 Audits
  • Medical device Quality Audits ISO13485

Assuring Compliance with Audit-Readiness

Techsol Regulatory Compliance

Let Us Know How We Can Help You