Elevate Your Compliance

At Regultech Solutions Limited, we provide expert GXP, FDA 21 CFR Part 11, and EU GMP Annex 11 compliance services tailored for small biotech, pharmaceutical, and clinical research companies, ensuring precision and efficiency in meeting stringent GxP requirements.

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Contact Regultech Solutions Limited

Reach out to us for expert GXP, FDA 21 CFR Part 11 and EU GMP Annex 11 compliance support tailored for biotechnology and pharmaceutical industries.

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17 King Edwards Road, Ruislip, London, United Kingdom, HA4 7AE

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Phone: +44 079 49529863
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info@regultechsolutions.com
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Frequently Asked Questions

Navigate the complexities of regulatory compliance with our comprehensive FAQ. We've compiled answers to the most common questions about GxP, FDA regulations, and quality management in biotechnology and pharmaceutical industries.

What is GxP Compliance?

GxP is an umbrella term for Good Practice guidelines and regulations in various industries, including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP). It ensures quality, safety, and efficacy in pharmaceutical, biotechnology, and medical device sectors.

Why is FDA 21 CFR Part 11 Important?

FDA 21 CFR Part 11 provides guidelines for electronic records and electronic signatures, ensuring their reliability, trustworthiness, and equivalence to paper records. It's crucial for maintaining data integrity in regulated industries, particularly in pharmaceutical and clinical research.

How Often Should Compliance Audits Be Conducted?

Compliance audits should typically be conducted annually or whenever significant changes occur in processes, systems, or regulations. Regular internal audits help identify potential issues, ensure ongoing regulatory adherence, and maintain high-quality standards.

What Are the Consequences of Non-Compliance?

Non-compliance can result in severe consequences, including regulatory fines, product recalls, legal actions, loss of market authorization, damage to reputation, and potential suspension of business operations in regulated industries.

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Regulatory Compliance FAQ Illustration

Understanding Regulatory Compliance

Navigating the complex landscape of regulatory compliance can be challenging. Our Frequently Asked Questions (FAQ) section is designed to provide clear, concise answers to the most common queries in GxP, FDA regulations, and quality management.

Whether you're a small biotechnology startup, a clinical research organization, or a pharmaceutical company, understanding these critical regulatory requirements is essential for maintaining quality, safety, and legal compliance.

Get in Touch with Regultech Solutions Limited

Have questions regarding GXP, FDA 21 CFR Part 11, or EU GMP Annex 11 compliance? Fill out the form below, and our experts will provide you with the tailored guidance you need for your biotechnology, pharmaceutical, or clinical research company.