Regulatory Compliance
Advancing Aseptic Manufacturing: GRAM’s Vision for the Future of Sterile Drug Production
Aseptic manufacturing , Isolator technology, Automation and robotics, Flexible fill-finish capabilities, Advanced drug delivery systems, Regulatory compliance (Annex 1), Strategic partnerships, Patient-centric solutions
Strategic Roadmap for Biologics Manufacturing: Enhancing Efficiency and Flexibility
Biologics manufacturing, Strategic roadmap, Process characterization, Flexibility and efficiency, Regulatory compliance, Biomanufacturing technology roadmap, Precision medicines, Modular facilities, Continuous manufacturing
Navigating Complex Regulatory Landscapes: The Importance of External Support for Biotech Sponsors in IRB, IBC, DMCs, and EACs
Biotech sponsors, IRB (Institutional Review Board), IBC (Institutional Biosafety Committee), DMCs (Data Monitoring Committees), EACs (Ethics Advisory Committees), Regulatory compliance, Clinical trials, Gene therapy research, Risk management
Streamlining Drug Development: The Power of Phase-Appropriate Technology Transfers
Technology Transfer, Phase-Appropriate Technology Transfer, Drug Development, Pharmaceutical Manufacturing, CDMOs (Contract Development and Manufacturing Organizations), Regulatory Compliance, Innovation in Drug Development
Revolutionizing CAR-Ts: The Future of Automation and Decentralization in Cell and Gene Therapy Manufacturing
Automation, Decentralization, CAR-Ts, Cell and gene therapy manufacturing, Advanced therapies, Personalized medicine, Regulatory compliance, Quality management systems, Supply chain logistics, Digital solutions, Real-time monitoring, Patient-centered care
Optimizing Pharmaceutical Supply Chains: The Evolving Role of Third-Party Logistics Providers
Third-Party Logistics (3PL) Providers, Pharmaceutical Supply Chain, Pharma 4.0, Regulatory Compliance, Cold Chain Management, Data Mining and Management, Licensing Requirements