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Ingenium

Experts in Audit Representation & Regulatory Compliance Support

Expert Audit Representation & End-to-End Compliance Support

Minimize Risk. Maximize Compliance. Exceed Regulatory Expectations.

We specialize in representing organizations during critical audits and supporting audit execution teams with unmatched regulatory expertise. From
FDA inspections to ISO certifications and SaaS compliance checks, our tailored services help businesses across medtech, pharma, CROs, and technology platforms face audits with confidence, clarity, and control.

Trusted by global brands and startups alike, we ensure your compliance journey is not just passable—but exceptional.

Ingenium

Service We Provide

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Audit Representation(For Companies Being Audited)

We act as your internal compliance lead during audits handling communications, documentation, and real-time responses so your team stays confident and in control.

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Computerized Software Validation (CSV)

We provide comprehensive end-to-end CSV services to ensure your computerized systems meet regulatory requirements and operate reliably throughout their lifecycle.

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GDPR Compliance

We support organizations in meeting the General Data Protection Regulation (GDPR) requirements to safeguard personal data and maintain customer trust.

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Audit Execution Support (For Internal & Third-Party Auditors)

We support audit teams by validating documentation, identifying gaps, and preparing detailed reports—ensuring every audit is efficient and audit-ready.

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Sarbanes–Oxley Act (SOX) IT General Controls (ITGC)

We help organizations achieve and maintain SOX IT General Controls compliance by evaluating, implementing, and testing frameworks, ensuring reduced risk, stronger governance, and lasting audit readiness.

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PCI Compliance

We help businesses comply with the Payment Card Industry Data Security Standard (PCI DSS) to protect payment card data and reduce the risk of data breaches.

Why Ingenium ?

Your Trusted Partner in Compliance Audits

We go beyond generic consulting. Our tailored, audit-focused services are built around what truly matters—regulatory accuracy, audit day confidence, and measurable results. Here’s why companies across industries trust us:

1. Deep Regulatory Expertise

Our team brings hands-on experience across critical compliance domains—CSV, GxP (GLP, GMP, GCP, GDP, GcLP), ISO standards (13485, 27002), and SaaS compliance (SOC 2, HIPAA, GDPR). We don’t just understand the frameworks—we know how to make them audit-ready.

2. Proven Track Record of Success

We’ve supported 10+ audits globally, achieving zero non-conformities in over 95% of cases. Whether facing FDA, EMA, or ISO assessors, our clients consistently pass inspections with confidence and clarity.

3. End-to-End Audit Support

From gap assessments and documentation reviews to mock audits and real-time representation, we provide holistic support that simplifies the most complex regulatory requirements.

4. Audit-Specific Strategy, Not Generic Consulting

We focus exclusively on audit environments—which means we don’t offer generic compliance advice. Every engagement is tailored to prepare you for inspections, walkthroughs, and Q&A with auditors.

5. Flexible, Scalable Services

Whether you’re a medtech startup, a growing SaaS platform, or a global pharma company, our services scale with your needs—from single-project audit prep to enterprise-wide compliance programs.

6. Client-First, Results-Focused Approach

We don’t just “check the box.” Our team becomes an extension of yours—proactively identifying risks, building readiness, and minimizing disruption so you can focus on your business while we handle compliance precision.

Contact us

Location

Bangalore, India, Karnataka

EMail id

rajgadiraju@gmail.com

Contact No

+91 98805 99229

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    Address

    Ingenium

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