Experience the Regultech Solutions Advantage
GxP Compliance Services
Ensuring compliance with GXP, FDA 21 CFR Part 11, and EU GMP Annex 11 standards.
Expert Quality Assurance
Custom services tailored for small biotech and clinical research companies.
Precision in Compliance
Technical expertise to meet stringent GxP requirements with efficiency.
Tailored Solutions
Focused on the unique needs of your biopharmaceutical organization.
Audit Readiness & Regulatory Support
Preparing businesses for FDA, MHRA, and ISO audits, conducting internal assessments, and strengthening compliance posture.
Automated Testing Solutions
Automated & Manual Testing – Leveraging cutting-edge automation tools like Selenium, JMeter, and Postman to optimize validation, testing, and performance efficiency.
Cloud & Infrastructure Qualification
Ensuring AWS, Azure, and hybrid IT environments meet GxP and security compliance standards.
Process Optimization & Training
Enhancing operational workflows, streamlining SOPs, and training teams on best practices for CSV and IT quality.