Elevate Your Compliance Standards

At Regultech Solutions Limited, we specialize in providing expert GXP, FDA 21 CFR Part 11, and EU GMP Annex 11 compliance services tailored specifically for small biotechnology, pharmaceutical, and clinical research organizations.

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Ensuring Compliance in Regulated Industries

At Regultech Solutions Limited, we provide expert GXP, FDA 21 CFR Part 11 and EU GMP Annex 11 compliance, as well as Computerised Systems Assurance and quality assurance services tailored for small biotechnology, pharmaceutical, and clinical research companies. We specialize in helping regulated organizations meet stringent GxP (Good Practice) requirements with precision and efficiency.

Biotechnology: Precision in compliance for innovative research and applications.
Pharmaceuticals: Excellence in drug manufacturing and quality assurance.
Clinical Research: Expert alignment with rigorous regulatory standards.

By partnering with Regultech Solutions, you choose experts dedicated to advancing your compliance excellence while enhancing efficiency and reliability in your processes.

Discover Our Industry Expertise

Our Areas of Expertise

Elevate your compliance strategies with tailored expertise in GxP and regulatory standards.

GXP Compliance

Expertise in Good Practices designed for biotechnology and pharmaceutical sectors.

FDA 21 CFR Part 11

Confidence in electronic records and signatures for global regulatory compliance.

EU GMP Annex 11

Tailored support to ensure compliance with Annex 11 regulatory standards.

Computerised Systems Assurance

Assure your digital systems meet compliance requirements for regulated industries.

Success Stories

Discover how Regultech Solutions Limited has empowered biotechnology and pharmaceutical organizations to achieve compliance and operational excellence in their industries.

Expert Compliance Transition

We assisted a mid-sized pharmaceutical company in establishing compliance with FDA 21 CFR Part 11, leading to a 30% reduction in documentation errors.

Tailored Compliance Roadmaps

Our team designed a customized compliance strategy for a biotech startup, achieving full GxP certification in just six months.

Successful Systems Assurance

We collaborated with a clinical research firm to validate their computerized systems, ensuring compliance with EU GMP Annex 11 and facilitating seamless regulatory audits.

Boosted Operational Performance

Through our quality assurance services, a small biopharma company enhanced its operational efficiency by 40%, accelerating time-to-market for their innovative products.