BionetworkConsulting

Preclinical

PRE-CLINICAL

Laying the Groundwork for Regulatory Success

Before clinical trials begin, it's critical to ensure your systems, processes, and data meet regulatory expectations. At Bionetwork Consulting, we support pre-clinical research organizations by validating lab systems, establishing compliant documentation, and strengthening data integrity, setting a strong foundation for future clinical and regulatory milestones.

We understand the importance of early-stage alignment with FDA, EMA, and ICH guidelines. Our team helps you implement GxP-compliant digital infrastructure, perform system risk assessments, and prepare your documentation to support IND filings and regulatory audits.

PreClinical Services

Biostatistics and Data Analysis

Quality Management Systems (QMS)

Vendor Selection & Qualification

Gap Assessment and Remediation

Project & Risk Management

CTO Selection & Qualification

Lab Operations and Efficiency

CRO Selection & Qualification

Funding and Investment Strategies

Regulatory Strategy & Submissions

Research and Development (R&D) ​

Data Integrity and Software Implementation

Quality Assurance and Regulatory Compliance

Investigational Device Exemption (IDE)

Investigational New Drug (IND) Application ​

CDMO Vendor Selection Qualification & Oversight

Technology Transfer

Medical Writing

Staffing

Please reach out to us for a free consultation

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