Your Bioanalysis Partner
for End-to-End Biologic Development

Your Bioanalysis Partner for End-to-End Biologic Development

We help mid to large pharma unify their analytical workflows, eliminate inefficiencies, and meet regulatory expectations across every phase of development.

We help mid to large pharma unify their analytical workflows, eliminate inefficiencies, and meet regulatory expectations across every phase of development.

We help mid to large pharma unify their analytical workflows, eliminate inefficiencies, and meet regulatory expectations across every phase of development.

WHY IBIO CONSULTING?

WHY IBIO CONSULTING?

Why Pharma Chooses iBio Consulting

Your Bioanalysis Partner for End-to-End Biologic Development

We help pharmaceutical teams overcome analytical complexity with a coordinated, regulatory-ready approach built for biologics.

Expertise in Mass Spectrometry and Analytical Techniques

With decades of experience in LC-MS/MS and advanced analytical platforms for large molecules, we guide method development, validation, and troubleshooting across complex modalities. Our support ensures your assays meet the highest scientific and regulatory standards from preclinical through commercial stages.

Strategic Oversight from Bench to Submission

We provide end-to-end oversight for method transfers, CRO/vendor management, and regulatory submissions. Whether you're preparing for commercialization or navigating complex tech transfers, we serve as a trusted partner ensuring scientific integrity and business alignment.

Scalable Quality Systems Built for Growth

We assess and enhance your lab’s quality framework to support evolving regulatory demands and business expansion. From SOP development to audit readiness, our approach ensures data integrity, inspection preparedness, and sustainable compliance at every stage.

Customized Training and Team Development

We empower your staff through tailored training programs in analytical techniques, regulatory expectations, and operational best practices. Whether upskilling scientists or coaching lab leaders, we build technical confidence and cross-functional capability across your team.

We empower your staff through tailored training programs in analytical techniques, regulatory expectations, and operational best practices. Whether upskilling scientists or coaching lab leaders, we build technical confidence and cross-functional capability across your team.

SERVICES

SERVICES

Expert Consulting Built for the
Complexity of Biologics

Expert Consulting Built for the Complexity of Biologics

Whether you need full analytical oversight or targeted support, we offer a deep bench of scientific, regulatory, and operational services tailored to your biologic development challenges.

Whether you need full analytical oversight or targeted support, we offer a deep bench of scientific, regulatory, and operational services tailored to your biologic development challenges.

1.

Lab Operations

From SOP development to technical team coordination, we streamline lab workflows and manage third-party vendors to maximize operational efficiency across your programs.

Operational Efficiency and Lab Management
Technical SOP Writing and Review
CRO/CDMO Oversight
Strategic Planning and Growth
Method Validation Documents Writing and Review
Operational Efficiency and Lab Management
Technical SOP Writing and Review
CRO/CDMO Oversight
Strategic Planning and Growth
Method Validation Documents Writing and Review
Operational Efficiency and Lab Management
Technical SOP Writing and Review
CRO/CDMO Oversight
Strategic Planning and Growth
Method Validation Documents Writing and Review
Operational Efficiency and Lab Management
Technical SOP Writing and Review
CRO/CDMO Oversight
Strategic Planning and Growth
Method Validation Documents Writing and Review

2.

Quality

We help pharma organizations design, evaluate, and operationalize GxP-compliant quality systems—ensuring regulatory readiness, data integrity, and seamless inspection outcomes.

GxP Compliance and Readiness
Quality System Design & Operation
Auditing Services
Data Integrity Evaluation
Method Lifecycle Oversight
Training and SOP Development
Regulatory Support and Remediation
GxP Compliance and Readiness
Quality System Design & Operation
Auditing Services
Data Integrity Evaluation
Method Lifecycle Oversight
Training and SOP Development
Regulatory Support and Remediation
GxP Compliance and Readiness
Quality System Design & Operation
Auditing Services
Data Integrity Evaluation
Method Lifecycle Oversight
Training and SOP Development
Regulatory Support and Remediation
GxP Compliance and Readiness
Quality System Design & Operation
Auditing Services
Data Integrity Evaluation
Method Lifecycle Oversight
Training and SOP Development
Regulatory Support and Remediation

TESTIMONIALS

Trusted by Pharma Teams
Who Value Precision and Partnership

From early-stage program design to regulatory submission, our clients rely on iBio Consulting for deep scientific insight, operational clarity, and results that move programs forward with confidence.

TESTIMONIALS

Trusted by Pharma Teams Who Value Precision and Partnership

From early-stage program design to regulatory submission, our clients rely on iBio Consulting for deep scientific insight, operational clarity, and results that move programs forward with confidence.

TESTIMONIALS

Trusted by Pharma Teams
Who Value Precision and Partnership

From early-stage program design to regulatory submission, our clients rely on iBio Consulting for deep scientific insight, operational clarity, and results that move programs forward with confidence.

TESTIMONIALS

Trusted by Pharma Teams
Who Value Precision and Partnership

From early-stage program design to regulatory submission, our clients rely on iBio Consulting for deep scientific insight, operational clarity, and results that move programs forward with confidence.

ABOUT

Led by Deep Expertise.
Focused on Biologics. Trusted by Pharma.

Expert Consulting Built for the Complexity of Biologics

With over 23 years in the biologics CDMO space and 350+ client programs supported,

Joe’s expertise is both deep and proven across high-stakes environments.

With over 23 years in the biologics CDMO space and 350+ client programs supported,

Joe’s expertise is both deep and proven across high-stakes environments.

MEET THE FOUNDER

Dr. Joe Nawrocki brings over 23 years of experience as a senior scientific leader in the biologics CDMO space. As a Director of Analytical Sciences, he has provided expert support to more than 350 biopharma clients, guiding their programs from CMC development through commercial launch.


Joe specializes in analytical method development, transfer, and validation for drug substances and drug products. He’s known for combining deep scientific knowledge with regulatory awareness, operational efficiency, and the ability to solve complex technical challenges under pressure.


His leadership has helped organizations optimize lab operations, improve compliance, mitigate risk, and deliver consistent value across all phases of development. iBio Consulting was created to offer that same clarity, structure, and expert insight to mid and large-scale pharma teams working with biologics.

KEY EXPERTISE
  • Analytical Strategy for Biologics:
    Expert in designing end-to-end analytical frameworks that guide complex biologics from development through commercialization.


  • Protein Characterization & Mass Spectrometry:
    Deep hands-on experience with advanced techniques like LC-MS and LC-MSMS for solving high-stakes structural challenges.


  • Regulatory Submission Support:
    Proven success in preparing and reviewing analytical sections for INDs, BLAs, and other global regulatory filings.


  • GxP Compliance & Quality Integration:
    Strong track record of aligning scientific operations with cGMP standards and working closely with QA to ensure audit readiness.


  • Scientific Leadership & CRO/CDMO Oversight:
    Led high-performing teams and managed global vendor partnerships, driving quality outcomes, operational efficiency, and strategic alignment.

MISSION
VISION
MISSION
VISION
MISSION
VISION
MISSION
VISION

CONTACT

CONTACT

Let’s Talk About Your Bioanalytical Challenges

Whether you're preparing for a regulatory submission, scaling your analytical operations, or need expert insight on complex biologics, we're here to help. Start the conversation today.

Get expert insight on complex biologics and analytical strategy

Explore ways to improve lab operations and vendor oversight

Partner with a consultant who understands both science and execution