INSIGHTS ON REGULATORY COMPLIANCE

• Managing Compliance Risks With Cloud-Native EAM/CMMS

  What separates systems that maintain compliance effortlessly from those that struggle? Test mobile offline signatures, automated OOT workflows, and integration traceability during vendor evaluations.

• Overcoming The Data Hurdle: Defining 'Good Data' For Agentic AI

  Agentic AI delivers real value only when supported by contextualized data. See how unified data fabrics transform siloed records into actionable intelligence, enabling faster, more reliable decisions.

• Accelerated Development Of Solid Oral Dosage Formulation For IND Submission

  This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.

• New Year, New Biopharma: Game Changers We're Betting On

  Digital innovation and regulatory evolution are reshaping biopharma. From AI to breakthroughs in oncology and gene editing, discover the trends and challenges that could define the industry.

• MPLC System: Efficient Purification for Mid-Sized Therapeutics

  1/28/2026

  Discover how to enhance purification for mid-sized therapeutics with advanced pressure capabilities. Learn to balance automation and regulatory compliance for more reliable, precise batches.

• How Cell Therapy's Fundamentally Different Model Impacts Patients

  9/1/2026

  Examine the evolution of autologous CAR T therapies, their patient-specific manufacturing workflow, key similarities and differences with biologics production, and real-world approaches.

• Advancing Drug Safety And Improving R&D Productivity With The Liver-Chip S1

  12/10/2024

  Explore how the Emulate Liver-Chip S1 revolutionizes predictive toxicology by mimicking human liver biology, achieving superior sensitivity and specificity.

• A Risk-Based Decision Framework For Selecting Aseptic Barrier Technologies

  3/20/2026

  EU GMP Annex 1 requires a risk-based approach to selecting Isolators or RABS. This framework evaluates human intervention and decontamination to ensure robust sterility assurance.

• Boost Compliance And Efficiency With Real-Time Asset Management

  9/2/2025

  Explore a platform that empowers GMP-regulated industries with a unified EAM, CMMS, and APM platform to boost compliance, efficiency, and asset performance through real-time integration.