Full-Spectrum Clinical and Regulatory Consulting
Welcome to BioNetwork Consulting in San Diego—your trusted partner providing comprehensive clinical and regulatory consulting services tailored to the dynamic biotech and life sciences landscape of this vibrant region. With deep expertise spanning biostatistics, quality management, clinical operations, and regulatory affairs, we empower innovators to accelerate development, ensure compliance, and successfully bring new therapies and technologies to market.
Supporting Biotech Growth with Data, Quality & Compliance Services
San Diego’s thriving biotech ecosystem demands partners who understand the intricate regulatory environment, evolving compliance standards, and the science behind groundbreaking therapies. At BioNetwork Consulting, we offer integrated solutions across the entire product lifecycle—from early research through clinical trials, regulatory submission, and commercialization. Our multidisciplinary team delivers expert support designed to optimize operations, manage risk, and ensure the highest standards of quality.
Biostatistics and Data Analytics San Diego
Robust data analytics and statistical modeling are foundational to successful clinical development. Our biostatistics experts provide study design consultation, data analysis, adaptive trial planning, and final statistical reporting, ensuring that your clinical data withstands regulatory scrutiny and supports confident decision-making.
Quality Management System San Diego
A compliant and effective quality management system is vital to sustaining regulatory compliance and operational excellence. We help design, implement, and optimize quality management systems aligned with GxP standards, tailored to your company’s size and risk profile.
Vendor Selection and Qualification San Diego
Selecting the right partners—from CROs to CDMOs—is critical to your project’s success. Our vendor qualification services include thorough due diligence, audits, and ongoing oversight to ensure vendor capabilities and compliance meet your exacting standards.
Gap Assessment and Remediation San Diego
Our targeted gap assessments identify weaknesses in compliance, quality systems, or operational processes. We then develop practical remediation plans and work alongside your team to implement corrective actions that prepare you for inspections and audits.
Project and Risk Management San Diego
Managing complex projects with multiple stakeholders requires rigorous coordination and risk mitigation. We provide structured project management, milestone tracking, and risk assessments to help you meet timelines and budget goals with confidence.
CTO Selection and Qualification San Diego
A strong CTO can make all the difference in technology-driven organizations. We assist with defining technical leadership needs, candidate evaluation, and onboarding strategies to ensure your CTO aligns with your company’s vision and operational goals.
Lab Operations and Efficiency San Diego
Optimizing laboratory operations improves throughput, data quality, and regulatory readiness. Our services include workflow analysis, SOP development, and resource allocation to increase efficiency while maintaining compliance.
CRO Selection and Qualification San Diego
Choosing the right CRO is essential for smooth clinical execution. We perform detailed CRO evaluations, contract reviews, and quality audits to ensure alignment with your project requirements and regulatory expectations.
Funding and Investment Strategies San Diego
Capitalizing on investment opportunities requires strategic planning and compelling documentation. We support fundraising efforts by developing clear scientific narratives, market analysis, and investor-ready materials to help you secure the funding you need.
Regulatory Strategy and Submissions San Diego
Navigating the complex regulatory landscape can be daunting. Our experts craft tailored regulatory strategies, prepare submissions including IND, IDE, and NDA, and coordinate agency interactions to accelerate your product’s path to approval.
Research and Development San Diego
We support innovation through strategic planning and operational oversight of R&D programs—bridging early discovery, translational science, and clinical research to help you achieve your development milestones efficiently.
Data Integrity and Software Development San Diego
Ensuring the integrity and security of your electronic data systems is crucial. Our team specializes in computer system validation, compliant software development, and data governance strategies to protect your critical data assets.
Quality Assurance and Regulatory Compliance San Diego
From deviation management to CAPA implementation and audit readiness, we help you maintain robust quality assurance programs that meet FDA and global regulatory standards, ensuring compliance throughout your operations.
Investigational Device Exemption San Diego
If you’re developing medical devices, our regulatory specialists guide you through IDE submissions, clinical trial planning, and FDA interactions to facilitate timely approval and market access.
Investigational New Drug Application San Diego
We assist pharmaceutical developers with IND submissions, including pre-IND meetings, protocol development, and regulatory correspondence to ensure efficient initiation of clinical trials.
CDMO Vendor Selection Qualification and Oversight San Diego
Our vendor qualification extends to CDMOs, ensuring your contract manufacturers comply with GMP standards and can reliably deliver clinical or commercial product according to your specifications.
Technology Transfer San Diego
Effective technology transfer is key to scalable manufacturing and quality control. We support seamless transitions from R&D to manufacturing through documentation, training, and process optimization.
Medical Writing San Diego
Clear, precise documentation supports regulatory submissions and scientific communication. We offer medical writing services ranging from clinical study reports and protocols to regulatory dossiers and scientific publications.
Clinical Operations San Diego
From site selection to patient management and data monitoring, our clinical operations team ensures that trials run smoothly, stay compliant with GCP standards, and meet recruitment targets.
Clinical Trial Monitoring San Diego
Experienced clinical research associates provide onsite and remote monitoring, source data verification, and site compliance checks to maintain trial integrity and participant safety.
Internal and Supplier Audits San Diego
We conduct thorough audits to evaluate compliance within your organization and across your supplier network—identifying gaps, driving corrective actions, and reducing risk.
FDA Inspection Readiness San Diego
Prepare for FDA inspections with mock audits, comprehensive training, and tailored readiness programs to minimize surprises and enhance regulatory interactions.
GxP Training San Diego
We offer customized training programs that cover GMP, GLP, and GCP principles, ensuring your team is knowledgeable and confident in meeting regulatory requirements.
Computer System Validation San Diego
Our CSV services include validation planning, protocol development, execution, and documentation—ensuring your computerized systems comply with regulatory standards such as 21 CFR Part 11.
Qualification and Validation San Diego
We support equipment and facility qualification (IQ/OQ/PQ), ensuring that critical systems meet regulatory requirements and operate within validated parameters.
Regulatory CMC Support San Diego
Optimize your chemistry, manufacturing, and controls documentation for regulatory submissions with our expert guidance—addressing stability, manufacturing processes, and product characterization.
Strategic Advising San Diego
Our consultants offer strategic insights on portfolio development, regulatory pathways, and market entry, helping you navigate complex decisions with confidence.
Process Optimization San Diego
Applying Lean and Six Sigma principles, we help streamline manufacturing, clinical, and laboratory processes to improve efficiency, reduce costs, and enhance product quality.
Health Authority Meeting Support San Diego
Maximize the impact of your regulatory meetings with comprehensive preparation, including briefing books, presentation materials, and strategic counsel.
Commercialization San Diego
From launch planning to post-market surveillance, we provide support to help you successfully introduce products into the market and maintain compliance throughout their lifecycle.
Preclinical Services San Diego
Our preclinical experts assist with study design, vendor management, and data interpretation to ensure that early-stage research is robust and aligns with regulatory expectations.
Bionetwork Recruitment San Diego
We support your talent acquisition efforts with recruitment strategies for clinical, regulatory, and quality professionals—helping you build strong teams that propel your company forward.
Patient Recruitment San Diego
Effective patient recruitment is critical to clinical trial success. We offer data-driven recruitment strategies, site collaboration, and retention programs to help you meet enrollment targets.
Clinical Services San Diego
Our full suite of clinical services—from protocol development to trial closeout and reporting—ensures operational excellence, regulatory compliance, and timely delivery of quality data.
At BioNetwork Consulting, we are committed to supporting the San Diego life sciences community with comprehensive clinical, regulatory, and quality services. Our expert team works closely with you to address challenges, optimize processes, and advance your innovative therapies with confidence.