02.25.26 -- FDA's PreCheck Pilot Is Open: What You Need To Know To Apply

By fostering a culture of continuous improvement through internal audits, clinical research sites can identify non-compliance issues and enhance their research practices.

Navigate the regulatory ambiguity of RNA therapeutics. Use this guide to strengthen your Investigational New Drug filing process and accelerate the approval of novel nanomedicines today.

Compliance with EU GMP Annex 1 requires a strategic CCS. Learn how a framework based on people, communication, process, and continuous improvement enables systematic, long-term compliance.

Clinical data review needs centralized access and traceable workflows. Leveraging AI-automation and real-time collaboration drives faster, better-informed decisions and reduced compliance risk.

Facility shutdowns often compromise contamination control strategies. Transitioning from manual cleaning to automated bio-decontamination ensures a more effective facility restart, eliminating persistent mold risks.

Next generation sequencing technologies and workflow automation are accelerating genomic research. Compare key differences between sequencing methods and uncover strategies to boost efficiency.

Endonucleases are vital for clearing DNA impurities in manufacturing. See how a new enzyme performs against commercial options for AAV and LVV production in this detailed technical study.

Discover the key fabrics used in cleanroom wipes and how they impact performance, and understand the substrates, manufacturing methods, and essential attributes to help you choose the right wipe.

Demonstrating residual reagent clearance is a critical regulatory requirement in AAV manufacturing. Gain insight into how specialized assays and strategic partnerships can streamline your path to full compliance.

Learn how Quality by Design strategies can reduce regulatory burden, simplify post-approval changes, and improve lifecycle flexibility while maintaining product quality and supply continuity.