Cell and Gene Regulatory

  1. Biotech Wasn't Ready For AI's Speed; Here's How We Catch Up 12/5/2025

    Computational success is no stand-in for therapeutic readiness. Innovators must learn to discern between models rooted in science and those that speculate.

  2. Navigating Regulatory Expectations For Injectable Packaging 12/4/2025

    Explore insights on extractables, focusing on how they relate to the revised EU GMP Annex 1, new and evolved expectations under USP <382>, and the use of VHP decontamination in aseptic environments.

  3. How Mobile Clinics Advance Diversity In Clinical Research 12/4/2025

    Mobile clinics reduce participation barriers, enable more inclusive trials, deliver representative data, speed timelines, and advance equity in research.

  4. CDMO Media And Buffer Outsourcing: A Strategic Advantage 12/4/2025

    Learn how outsourcing cell culture media and buffers removes bottlenecks, freeing specialized CDMO resources. Ensure consistency, accelerate timelines, and streamline GMP readiness for client success.

  5. 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.

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

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

  7. 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.

  8. 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.

  9. Beyond The Checkpoint — Next-Gen Strategies In Immuno-Oncology 11/24/2025

    Gain a clearer view of the scientific, operational, and regulatory forces propelling the next wave of oncology innovation — and what they mean for sponsors advancing cutting-edge cancer therapies.

  10. Unlock The Future Of Market Access In 2026: A Guide To Navigating A Shifting Healthcare Landscape 11/24/2025

    Navigating the future healthcare landscape requires early strategic planning and organizational agility to manage policy shifts. From AI implementation to global pricing dynamics, understanding these trends is essential for ensuring timely patient access.