Full-Service Life Sciences Consulting in New York
At BioNetwork Consulting, we provide comprehensive life sciences consulting services to support biopharmaceutical, medical device, and diagnostics companies throughout every stage of development. Based in New York, our seasoned professionals bring deep domain knowledge and hands-on experience to help you navigate complex regulatory environments, streamline operations, and achieve faster time-to-market.
From Biostatistics and Data Analytics New York to Regulatory Strategy and Submissions New York, we deliver tailored, scalable solutions that enable innovation, ensure compliance, and optimize product lifecycle performance. Whether you’re a start-up preparing for preclinical milestones or an established company aiming to improve operational efficiency, BioNetwork Consulting is your trusted partner for success.
Expertise Across Biostatistics, Clinical, Regulatory & More
New York is a global hub for scientific innovation, and BioNetwork Consulting stands at the center of it, offering strategic guidance and operational support across a wide array of services tailored for life sciences organizations.
Biostatistics and Data Analytics New York
Our biostatistics experts help you design efficient clinical trials, analyze data accurately, and generate reliable insights. From study planning through regulatory submission, we ensure your data analytics meets the highest scientific and compliance standards.
Quality Management System New York
A strong Quality Management System (QMS) is critical to maintaining regulatory compliance. We help companies implement scalable, GxP-compliant systems that support consistent quality across clinical, laboratory, and manufacturing processes.
Vendor Selection and Qualification New York
Selecting and managing vendors is a high-stakes endeavor. Our consultants support vendor selection and qualification, ensuring CROs, CDMOs, and suppliers align with your quality, timeline, and regulatory requirements.
Gap Assessment and Remediation New York
Avoid costly delays and noncompliance. We conduct thorough gap assessments and implement risk-based remediation strategies to bring your processes, documentation, and systems into compliance.
Project and Risk Management New York
From timelines to deliverables, our team supports project management and risk mitigation strategies that help you stay on track across clinical, regulatory, and operational initiatives.
CTO Selection and Qualification New York
Choosing the right Chief Technology Officer is essential for innovative product development. We assist with CTO qualification, role definition, and alignment with strategic goals.
Lab Operations and Efficiency New York
Improve productivity, reduce cost, and meet compliance standards with our support in optimizing lab operations and efficiency. We streamline workflows and develop SOPs tailored to your lab environment.
CRO Selection and Qualification New York
We help you select and qualify Clinical Research Organizations (CROs) that align with your therapeutic area, regulatory scope, and operational needs. Our qualification process ensures transparency and reliability.
Funding and Investment Strategies New York
Prepare for funding rounds with expert guidance in pitch preparation, technical documentation, and market analysis. We support investment strategy development and due diligence documentation that resonates with investors.
Regulatory Strategy and Submissions New York
From Investigational New Drug (IND) to Investigational Device Exemption (IDE), we guide your regulatory submissions to FDA and global authorities. We develop and execute regulatory strategies that accelerate approval timelines.
Research and Development New York
Drive innovation with expert R&D support in preclinical design, IND-enabling studies, and translational science. We help you turn novel concepts into validated therapies.
Data Integrity and Software Development New York
Our consultants ensure data integrity across your systems, and provide custom software development compliant with 21 CFR Part 11 and international data management regulations.
Quality Assurance and Regulatory Compliance New York
We develop robust Quality Assurance (QA) frameworks to manage documentation, CAPAs, audits, and continuous improvement, ensuring your operations remain compliant and inspection-ready.
Investigational Device Exemption New York
Our regulatory experts manage every step of the IDE process—from early planning to FDA interactions—helping device sponsors launch compliant, successful clinical trials.
CDMO Vendor Selection Qualification and Oversight New York
From small-batch clinical production to commercial scale-up, we assist with CDMO selection, qualification, and oversight to ensure quality, capacity, and delivery performance.
Technology Transfer New York
We manage smooth, compliant technology transfers from R&D to manufacturing, including process validation, documentation, and interdepartmental coordination.
Medical Writing New York
Clear, compliant, and impactful documentation is essential. We provide expert medical writing for protocols, clinical study reports, briefing books, and submission dossiers.
Clinical Operations New York
Efficient, compliant clinical operations are critical to program success. We support study start-up, monitoring, site management, and trial close-out across therapeutic areas.
Clinical Trial Monitoring New York
Our experienced CRAs deliver high-quality clinical trial monitoring that ensures data accuracy, protocol adherence, and patient safety throughout your studies.
Internal and Supplier Audits New York
We perform independent, objective internal audits and supplier audits to identify risks, uncover gaps, and ensure compliance across your operations and third-party vendors.
FDA Inspection Readiness New York
Be prepared for every regulatory inspection. Our FDA inspection readiness services include mock audits, SOP evaluations, interview prep, and facility walkthroughs.
GxP Training New York
Keep your staff current with engaging, role-based GxP training across GMP, GLP, and GCP areas. Our customized programs reinforce compliance culture and operational excellence.
Computer System Validation New York
We deliver full Computer System Validation (CSV) support for clinical, laboratory, and manufacturing systems—ensuring you meet data integrity and regulatory standards.
Qualification and Validation New York
From process validation to equipment qualification, we provide comprehensive IQ/OQ/PQ protocol development, execution, and documentation to meet global compliance expectations.
Regulatory CMC Support New York
Our Regulatory Chemistry, Manufacturing, and Controls (CMC) experts support you in creating submission-ready documentation that ensures smooth regulatory interactions and product approvals.
Strategic Advising New York
Gain strategic insight from seasoned consultants with experience in FDA, pharma, biotech, and diagnostics. We offer strategic advising on development planning, go-to-market strategies, and portfolio management.
Process Optimization New York
Improve speed, quality, and cost-efficiency. Our process optimization services are rooted in Lean Six Sigma methodologies, helping you streamline operations and boost productivity.
Health Authority Meeting Support New York
From pre-IND to Type C meetings, we prepare your team for successful interactions with regulators. Services include briefing package preparation, Q&A development, and rehearsal support.
Commercialization New York
Ready to go to market? We support commercialization strategies, market access planning, launch readiness, and post-market surveillance to maximize impact and ROI.
Preclinical Services New York
We manage your preclinical services with expert design, vendor oversight, and regulatory coordination to prepare for IND or IDE filings efficiently.
Bionetwork Recruitment New York
Build the right team for success. We offer life sciences recruitment services for roles in R&D, regulatory, quality, clinical operations, and executive leadership.
Patient Recruitment New York
Accelerate your studies with targeted patient recruitment strategies. We partner with sites and utilize data-driven outreach tools to meet enrollment goals faster.
Clinical Services New York
Our full-suite clinical services include protocol development, trial management, site support, and data management—all delivered by experienced clinical professionals.
Accelerate Your Life Sciences Journey with BioNetwork Consulting in New York
Whether you’re launching a new therapy, scaling your clinical programs, or preparing for FDA engagement, BioNetwork Consulting delivers the insight and execution needed to move forward with confidence. From biostatistics to commercialization, our team is committed to helping you navigate the complex journey of life sciences innovation.