Services we offer

At RegTech Services, we provide meticulously tailored solutions designed to meet the unique and evolving needs of your organization, ensuring full compliance with stringent global regulatory standards such as ICH-GCP, ISO 13485, FDA 21 CFR Part 11, and EU MDR. Our extensive and comprehensive suite of services includes:

🔍 Independent GxP Audits
Thorough audits encompassing clinical trials, pharmacovigilance, manufacturing, and laboratory operations, aimed at guaranteeing uncompromising compliance and maintaining the highest levels of quality assurance.

📋 Regulatory Compliance Consulting
Expert gap assessments combined with precise SOP development and detailed inspection readiness preparations, all designed to keep your organization consistently audit-ready and fully compliant with regulatory expectations.

🧪 Clinical Research Support
Comprehensive support including vendor audits, site qualification processes, and strategic monitoring reviews, crafted to streamline and optimize your clinical research operations for efficiency and regulatory adherence.

⚙️ Medical Device Consulting
Specialized services in ISO 13485 implementation, meticulous technical documentation review, and proactive risk management strategies, all tailored to facilitate seamless medical device development and ensure robust regulatory compliance.

🖥️ IT Validation
Industry-seasoned CSV consultants delivering thorough and reliable validation services, catering to a broad range of projects from greenfield initiatives to top-tier manufacturing facilities, ensuring your IT systems meet the highest compliance standards.