At BioNetwork Consulting, our preclinical consulting services are designed to support organizations through every phase of early development — from laboratory setup to regulatory submission. We provide hands-on, science-driven guidance that aligns your operations with both local and international compliance standards.

1. Computer System Validation (CSV) for Preclinical Labs

In the preclinical phase, data accuracy and reproducibility are paramount. Our CSV specialists ensure your laboratory and digital systems — such as LIMS, ELN, and chromatography data systems — comply with FDA 21 CFR Part 11, EMA Annex 11, and GLP regulations.

We offer:

• Validation master plans and risk assessments

• Detailed test scripts and traceability matrices

• Data integrity and audit trail verification

• SOP development and lifecycle documentation

By validating your preclinical systems early, you mitigate risk, streamline regulatory review, and create a foundation for smooth clinical trial transitions.

2. Regulatory Documentation and IND Preparation

Submitting a successful Investigational New Drug (IND) application depends heavily on the quality and compliance of preclinical data. Our regulatory consultants assist in preparing submission-ready documentation that meets FDA and ICH requirements.

We support your team with:

• Preclinical study design reviews for compliance

• Compilation of study reports and validation summaries

• Gap assessments for GLP and data traceability

• Audit preparation and mock inspections

Our approach ensures that your preclinical documentation is scientifically sound, traceable, and aligned with global regulatory expectations.

3. Quality Assurance and Data Integrity

Ensuring data integrity across preclinical workflows is a top priority for regulatory agencies. BioNetwork Consulting’s QA experts implement proactive systems to prevent data loss, unauthorized access, or inconsistent recordkeeping.

We help you establish:

• Comprehensive data governance frameworks

• Quality management systems (QMS) for preclinical operations

• Internal auditing programs and corrective action plans

• GLP compliance training for laboratory personnel

By embedding data integrity principles into your operations, we help you build credibility and regulatory resilience.

4. GxP System Implementation and Risk Management

Transitioning from discovery to preclinical stages often requires integrating GxP-compliant digital systems. Our consultants guide you through selecting, configuring, and validating platforms that support scientific excellence and compliance.

Our services include:

• System implementation strategy and vendor qualification

• Risk-based validation planning

• Change control and system upgrade support

• Continuous monitoring and maintenance guidance

With BioNetwork Consulting, your preclinical infrastructure remains compliant, scalable, and adaptable to future clinical and commercial needs.

Why Choose BioNetwork Consulting for Preclinical Projects

At BioNetwork Consulting, we understand that preclinical development sets the stage for everything that follows. Our team brings a blend of regulatory insight, technical expertise, and industry experience to help clients navigate the challenges of early-stage research with confidence.

Regulatory Expertise You Can Trust

Our consultants have decades of experience supporting pharmaceutical, biotech, and medical device companies through GLP compliance, IND submissions, and system validation. We stay ahead of evolving regulations to ensure your operations are always inspection-ready.

Tailored, Scalable Solutions

No two preclinical programs are alike. Whether you’re a startup validating your first lab system or a global enterprise optimizing your quality framework, we tailor our solutions to fit your specific goals, risk profile, and regulatory environment.

Global Reach, Local Insight

Operating across North America, Europe, and Asia, we understand both global regulatory frameworks and local market nuances. Our consultants ensure your preclinical operations align seamlessly with FDA, EMA, MHRA, and PMDA standards.

Proven Results, Trusted Partnerships

We’ve helped organizations worldwide accelerate their path from discovery to clinical readiness. By prioritizing transparency, efficiency, and long-term impact, we’ve built partnerships grounded in trust and measurable success.

Empowering the Transition from Preclinical to Clinical Development

A successful preclinical program not only satisfies regulatory requirements but also positions your organization for a smoother clinical trial initiation. Our experts bridge the gap between preclinical validation and clinical execution, ensuring continuity in compliance, data integrity, and operational readiness.

We support:

• IND-enabling toxicology studies

• Preclinical validation of manufacturing processes

• Documentation transfer for clinical study setup

• System audits prior to clinical use

By addressing potential compliance issues early, you reduce costly delays and strengthen your regulatory submissions.

Partner with BioNetwork Consulting: Your Preclinical Compliance Ally

At BioNetwork Consulting, we view ourselves not just as consultants — but as collaborators in your scientific journey. We integrate seamlessly with your internal teams, providing the expertise, structure, and oversight required to turn promising research into successful, compliant innovation.

Whether you’re preparing for your first IND submission or refining your preclinical QA systems, we’re here to guide you every step of the way.

Let’s build the foundation for your regulatory success — one compliant step at a time.

Ready to Strengthen Your Preclinical Operations?

Contact BioNetwork Consulting today to learn how our preclinical compliance, validation, and quality assurance experts can help you accelerate discovery while maintaining regulatory excellence.