Regulatory Solutions

  1. Technology To Enable Remote Participation 12/15/2025

    Secure, flexible virtual visits boost trial efficiency and patient engagement. Global reach, device integration, and intuitive scheduling reduce disruptions while ensuring compliance and data security.

  2. Navigate The Future: Your Essential Guide To ICH E6(R3) GCP Changes 12/15/2025

    The long-awaited ICH E6(R3) guideline is here and will reshape clinical trial standards. Get ahead of the transition with a detailed comparison and strategic insights designed for sponsors and CROs.

  3. Why Multi-Omic Insights Demand A Multi-Omic Strategy 12/10/2025

    Gene therapy development faces complex scientific and regulatory challenges. Success requires optimized vectors, robust preclinical studies, biomarker strategies, and coordinated FDA engagement.

  4. Regulatory Strategy And Submission Support 12/2/2025

    This Regulatory Operations Team enables biotech and pharmaceutical companies to focus on innovation while ensuring a smooth, compliant path to market entry.

  5. Toxicology Support: Regulatory Strategy And Submission Support 12/2/2025

    Eliminate delays and ensure seamless regulatory alignment with an experienced toxicology services team.

  6. CMC: Accelerate Your Drug Development With A Global Partner 12/2/2025

    With the right Chemistry, Manufacturing & Controls (CMC) consulting services, your organization can excel in early-stage strategizing, accelerate timelines, optimize processes, and reduce costs.

  7. Trusted Partner For Clinical And Regulatory Success 12/2/2025

    Novotech’s Regulatory Affairs team offers customized, end-to-end clinical and regulatory solutions, guiding biotechnology, pharmaceutical, and medical device companies through the entire product lifecycle.

  8. How AI Is Setting A New Standard In Clinical Development 11/13/2025

    Learn how to adopt artificial intelligence in practical, measurable ways, from protocol feasibility and cohort modeling to clinical trial disclosure and transparency.

  9. IVD And CDx: Comprehensive Services From Research To Regulatory 10/15/2025

    Navigating diagnostic development requires deep scientific expertise and adept regulatory support. Comprehensive solutions offer biospecimens, biomarker development, clinical trial support, and global regulatory services.

  10. Beyond Traditional TRSM: Transforming Clinical Operations At Scale 10/3/2025

    Explore how organizations can transform from managing dozens of siloed, protocol-specific RTSM implementations to achieving unified, portfolio-level clinical operations.