I'ni Pharma And Biotech Consulting LogoI'NI Pharma And Biotech Consulting

GCP Good Clinical Practice Auditing

Ensuring Global Compliance & Operational Integrity

EXPERTISE. COMPLIANCE. RELIABILITY.

I'NI delivers comprehensive GxP auditing and regulatory compliance support tailored to pharmaceutical, biotech, and medical device sectors.

What We Offer

From system evaluations to inspection readiness, I'ni Pharma And Biotech Consulting partners with clients to ensure operational excellence and regulatory alignment at every stage of development.

Our Services
GMP Auditing & Compliance
Inspection Readiness
Mock Inspections & GAP Analysis
Regulatory Risk Assessment
Vendor Qualification Audits
Remote Consulting Support

The I'NI Approach

At I'NI, our consultants combine deep regulatory insight with practical solutions to address compliance risks efficiently and effectively.

We embrace a risk-based methodology, focusing on the issues that matter most to your business.

We believe in true collaboration and value long-term partnerships with our clients.

True Innovation

At I'ni Pharma And Biotech Consulting, innovation is integral to how we deliver compliance solutions. We continuously refine our methodologies to adapt to evolving global standards and client expectations.

Our forward-thinking approach combines regulatory expertise with emerging technologies, enabling us to support clients with smarter, more effective strategies that lead the industry forward.

Innovation at I'NI
I'NI Team

Our Experts Drive Our Success

I'ni Pharma And Biotech Consulting is powered by a team of highly experienced consultants, each bringing deep expertise in regulatory compliance and GxP auditing across life sciences sectors.

With global presence and regional insights, our team ensures tailored solutions and efficient execution—no matter where our clients are located.

Inspiring Progress in Life Sciences

I'ni Pharma And Biotech Consulting has been a trusted partner for regulated industries by delivering expert GxP compliance solutions with integrity and precision.

Our independent and client-focused approach ensures agile support and tailored solutions at every stage of the product lifecycle.

Clients count on I'NI for consistent quality, professional insight, and the confidence needed to navigate evolving regulatory landscapes.

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I'ni Pharma And Biotech Consulting empowers clients with the confidence
that their compliance programs align with global
regulatory expectations and best practices.

WHAT I'ni Pharma And Biotech Consulting CLIENTS SAY

I would like to thank you and your staff for your fine support and help throughout all stages of the audit process; it has been excellent.

J.M.
Country Manager, International Biotech Company

ARTICLES AND INSIGHTS FROM I'ni Pharma And Biotech Consulting

RQA Course: A System Approach to Good Pharmacovigilance Practice

RQA Course: A System Approach to Good Pharmacovigilance Practice

INI Consulting is proud to support the professional development of pharmacovigilance (PV) specialists across the industry through active participation in the RQA’s highly...

DIA 2025 Global Annual Meeting | Washington, DC

DIA 2025 Global Annual Meeting | Washington, DC

INI Consulting looks forward to attending the upcoming DIA Global Annual Meeting 2025 that will take place in Washington, DC from 15–19 June.

2025 European QA Virtual Conference

2025 European QA Virtual Conference

INI Consulting Consulting is proud to be a Silver Sponsor of the 2025 RQA European QA Virtual Conference, the must-attend event for quality assurance...

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