Comprehensive Life Science Consulting in Chicago
Welcome to BioNetwork Consulting – Chicago, your trusted partner in delivering full-spectrum life sciences consulting. We specialize in guiding pharmaceutical, biotechnology, medical device, and diagnostics companies through the complexities of development, regulation, and commercialization.
As a life sciences hub, Chicago offers a rich ecosystem for innovation, and we are here to help your organization thrive within it. From Biostatistics and Data Analytics Chicago to Regulatory Strategy and Submissions Chicago, our team of experts provides strategic and operational support across every stage of the product lifecycle.
Whether you’re launching a new therapy, scaling your clinical trials, or optimizing your lab operations, BioNetwork Consulting Chicago delivers tailored solutions that drive compliance, efficiency, and innovation.
Expert Support in Clinical, Regulatory & Compliance Services
Our consultants combine hands-on industry experience with deep regulatory insight to support companies of all sizes. From preclinical through commercialization, our services are designed to ensure scientific rigor, operational excellence, and global compliance.
Biostatistics and Data Analytics Chicago
We provide advanced biostatistical services to support clinical trial design, sample size determination, endpoint analysis, and data interpretation. Our experts deliver statistically sound strategies and data presentations suitable for FDA submissions and regulatory audits.
Quality Management System Chicago
We help organizations develop, implement, and optimize Quality Management Systems (QMS) that align with global GxP standards. Whether you’re a startup building from scratch or an enterprise undergoing transformation, our QMS frameworks support consistency, compliance, and scalability.
Vendor Selection and Qualification Chicago
Choosing the right partners is vital. We support vendor selection and qualification for CROs, CDMOs, labs, and software providers—ensuring they meet your technical, regulatory, and operational needs through comprehensive assessments and ongoing oversight.
Gap Assessment and Remediation Chicago
We conduct in-depth gap assessments to identify areas of non-compliance across clinical operations, quality systems, and data integrity. Our remediation strategies are practical, risk-based, and aligned with regulatory expectations.
Project and Risk Management Chicago
Our seasoned project and risk managers ensure that development activities stay on time, within scope, and on budget. We implement project controls and risk mitigation plans tailored to your milestones and resources.
CTO Selection and Qualification Chicago
We support CTO selection and qualification to help you build a leadership team aligned with your R&D goals, technical vision, and investor expectations. Our process ensures a strategic match between candidate and company.
Lab Operations and Efficiency Chicago
Optimize your scientific operations with our support in lab workflows, documentation, automation, and Lean lab principles. We enhance throughput, minimize downtime, and ensure audit-readiness in research and clinical labs.
CRO Selection and Qualification Chicago
We assist in CRO selection and qualification by evaluating their capabilities, quality history, compliance records, and therapeutic area expertise. Our due diligence ensures your trials are managed by trusted partners.
Funding and Investment Strategies Chicago
Attract funding with a strong scientific and business case. We assist with investment strategies, pitch decks, technical storytelling, and due diligence support for angel, VC, and institutional fundraising.
Regulatory Strategy and Submissions Chicago
Navigate global and U.S. regulations with ease. We develop regulatory roadmaps and prepare submissions including INDs, IDEs, NDAs, and BLAs. Our team manages timelines, briefing books, and communication with the FDA and other regulatory bodies.
Research and Development Chicago
Accelerate your research and development initiatives through expert guidance in experimental design, protocol development, preclinical vendor management, and early-phase planning.
Data Integrity and Software Development Chicago
Ensure your systems meet 21 CFR Part 11, GAMP 5, and EU Annex 11 standards. We assess data integrity risks, develop audit trails, and offer custom software development to support regulated processes.
Quality Assurance and Regulatory Compliance Chicago
Our QA and regulatory compliance experts implement systems, perform audits, and manage CAPAs to ensure adherence to GMP, GLP, and GCP regulations.
Investigational Device Exemption Chicago
We manage IDE submissions for medical device sponsors, including study planning, pre-sub meetings, and FDA interactions, ensuring smooth initiation of clinical trials.
Investigational New Drug Application Chicago
We offer full support for Investigational New Drug Applications, including CMC documentation, clinical protocols, safety assessments, and regulatory correspondence.
CDMO Vendor Selection Qualification and Oversight Chicago
Ensure successful manufacturing partnerships with our CDMO selection and qualification services. We assess capabilities, review GMP compliance, and provide ongoing oversight to support your scale-up and commercialization plans.
Technology Transfer Chicago
We manage seamless technology transfers from development to manufacturing, including SOPs, batch records, process validation, and facility readiness reviews.
Medical Writing Chicago
Our medical writers develop submission-ready documents including protocols, investigator brochures, clinical study reports, and regulatory responses—all aligned with global submission requirements.
Clinical Operations Chicago
We deliver end-to-end clinical operations support, including trial planning, site management, monitoring coordination, and regulatory documentation to keep your studies running smoothly.
Clinical Trial Monitoring Chicago
Experienced CRAs ensure protocol adherence and data integrity across trial sites. Our clinical trial monitoring services include risk-based monitoring, source data verification, and site training.
Internal and Supplier Audits Chicago
Protect your business and ensure compliance with regular internal and supplier audits. We evaluate quality systems, conduct audit trails, and issue actionable reports and CAPAs.
FDA Inspection Readiness Chicago
We prepare your team for FDA inspections with mock audits, facility walkthroughs, SOP reviews, and interview preparation. Our goal: zero surprises during your inspection.
GxP Training Chicago
We offer custom GxP training programs in GMP, GCP, and GLP, tailored to your team’s needs and regulatory expectations. Training includes workshops, eLearning, and onsite programs.
Computer System Validation Chicago
Ensure software and electronic systems are compliant and validated. Our Computer System Validation (CSV) services cover system planning, testing, and documentation per FDA and EMA standards.
Qualification and Validation Chicago
From lab equipment to production lines, we manage IQ, OQ, and PQ protocols and provide full qualification and validation documentation for facilities, systems, and processes.
Regulatory CMC Support Chicago
Our Regulatory CMC experts assist with authoring and reviewing Module 3 documents, managing change controls, and aligning manufacturing data with your regulatory submissions.
Strategic Advising Chicago
Make smarter decisions with support from our senior consultants. We offer strategic advising on development paths, regulatory milestones, clinical investment, and portfolio strategy.
Process Optimization Chicago
Using Lean Six Sigma and industry best practices, we evaluate and enhance your development and production workflows through process optimization strategies.
Health Authority Meeting Support Chicago
We help you prepare for health authority meetings with briefing books, background packages, question/answer prep, and meeting rehearsals to align your team with regulators.
Commercialization Chicago
We assist with market entry strategies, pricing models, access planning, and post-market surveillance. Our commercialization services position your product for long-term success.
Preclinical Services Chicago
We manage your preclinical development from early-stage R&D to IND-enabling studies. Services include vendor oversight, study design, and GLP audit readiness.
Bionetwork Recruitment Chicago
Build a high-performance team with our recruitment services focused exclusively on life sciences. We place professionals in regulatory, clinical, quality, and executive leadership roles.
Patient Recruitment Chicago
Accelerate enrollment with customized patient recruitment campaigns, site engagement strategies, and retention programs that meet your diversity, timing, and budget goals.
Clinical Services Chicago
Our full-service clinical capabilities support every phase of clinical research—from trial design and execution to data management and submission support.
Partner With BioNetwork Consulting Chicago
With expertise across clinical operations, quality systems, regulatory strategy, and commercialization, BioNetwork Consulting Chicago delivers trusted, compliant, and results-driven support for life sciences innovators. Whether you’re filing your first Investigational New Drug Application Chicago or preparing for FDA inspection readiness Chicago, our consultants are ready to support your journey.