With experienced audit professionals and regulatory consultants, we bring clarity to complex frameworks like CSV, GxP, ISO standards, SaaS compliance, and more. Our goal is to ensure that every audit is not only manageable but becomes a strategic advantage for your business.

Ingenium

About Us

Experts in Audit Representation & Regulatory Compliance Support

We are a specialized compliance consulting firm dedicated to helping businesses navigate the most critical phase of their regulatory journey: the audit. Whether you’re being inspected by the FDA, preparing for an ISO certification, or validating a SaaS platform on RxCloud—we represent you with confidence, precision, and deep domain expertise.

Our Mission

To empower organizations with the confidence, clarity, and capability to succeed in every audit—by delivering industry-specific regulatory expertise, real-time support, and structured audit execution strategies that reduce risk and maximize compliance outcomes.

Our Vision

To be the most trusted global partner for organizations seeking audit excellence—where compliance is no longer a challenge, but a core strength. We envision a future where companies of all sizes can face audits without stress, equipped with systems, support, and strategies that ensure zero non-conformities and long-term regulatory success.

Who We Are

We are a team of dedicated audit professionals, compliance consultants, and regulatory strategists with deep expertise in GxP, CSV, ISO, SaaS, and cloud-based systems like RxCloud. With experience supporting over 100+ audits globally, we specialize in representing organizations during critical inspections and supporting those conducting them.

Our firm is built on one core principle: compliance doesn’t have to be stressful. We combine domain mastery with structured methodologies to help businesses across industries simplify audits, reduce non-conformities, and meet the highest regulatory standards.

Our Impact

Numbers Speak For Themselves

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What Sets Us Apart

  • Audit-Focused Approach – We’re not general compliance consultants. Our services are purpose-built for audit success.

  • Global Regulatory Insight – FDA, EMA, ISO, HIPAA, SOC 2—you name it, we’re fluent in it.

  • Tailored Support – Whether you’re a medtech firm, pharma company, SaaS provider, or CRO, we align with your environment and processes.

  • Real-Time Representation – From mock inspections to audit day responses, we operate like your internal compliance partner.

Industries We Serve

  • Life Sciences & Pharmaceuticals

  • Medical Devices & Digital Health

  • SaaS & Cloud-First Tech Platforms

  • Clinical Research Organizations (CROs)

  • Regulated Startups & Scale-ups

Testimonials

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Jan Masters
Designer
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Jane Wilcox
Designer
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Dan Ellis
Designer

Contact us

Location

Bangalore, India, Karnataka

EMail id

rajgadiraju@gmail.com

Contact No

+91 98805 99229

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    Ingenium

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