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Our integrated preclinical services provide biotechnology and pharmaceutical companies with complete drug development solutions.

Study Design Consultation

Effective research starts here. We excel at crafting bespoke, validated study protocols for robust, high-quality data collection. Our designs are optimised to answer critical questions efficiently, reducing the risk of costly study failures.

  • Tailored Protocols: Protocols are customised based on compound, target, and disease area.
  • Validation Focus: Ensuring your studies meet statistical power and regulatory expectations.
  • Unique Insight: Protocols are grounded in our practical knowledge of laboratory execution and logistics.

Preclinical Strategy Development

We provide the complete architectural blueprint for your compound’s journey. Our focus is on building efficient, end-to-end development plans for your compound, integrating non-clinical milestones with commercial goals.

  • Strategic Roadmap: Defining clear Go/No-Go decisions and critical path timelines.
  • Resource Optimisation: Planning studies to save time and resources without compromising data quality.
  • Unique Insight: We forecast potential delays or issues based on real-world development histories.

Regulatory Pathway Guidance

Navigate the complex global regulatory landscape with assurance. We offer expert oversight to ensure your studies meet global submission standards, anticipating requirements for the TGA, FDA, and EMA.

  • Global Compliance: Guidance to ensure studies are compliant with relevant GxP standards.
  • Risk Mitigation: Identifying and addressing potential regulatory challenges early in the planning phase.
  • Unique Insight: Our experience managing data integrity provides a crucial advantage in compliance.

IND Preparation Support

The final hurdle requires precision. We provide comprehensive review and assembly of your data for successful filing, ensuring the non-clinical section of your Investigational New Drug (IND) application is complete, coherent, and compelling.

  • Document Review: Thorough auditing and formatting of all non-clinical study reports and summaries.
  • Submission Strategy: Assisting with the final organisation and sequencing of the IND application.
  • Unique Insight: We focus on the clarity and scientific coherence that streamlines the regulatory review process.

Additional Core Services

We complement the above strategic services with critical expertise in early compound assessment and project oversight.

  • Candidate Selection Consulting: We help clients identify the most promising compounds for development by applying rigorous scientific and commercial criteria to your compound library evaluation.
  • Toxicology and Efficacy Planning: We draw on our laboratory background to design optimal testing strategies for both safety and effectiveness studies, ensuring robust, ethical, and efficient data generation.
  • Integrated Project Management: Our consulting ensures seamless coordination between different testing phases, vendors, and regulatory milestones, keeping your project on schedule and budget.

Advance Your Compound

Your preclinical success starts with a conversation. Let vivoPharm’s unique blend of laboratory experience and strategic consulting guide your next steps efficiently and reliably.

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