INSIGHTS ON REGULATORY COMPLIANCE
-
![GettyImages-508496956-dna]( "Streamlining Data For Efficient Therapeutic Manufacturing")
Streamlining Data For Efficient Therapeutic ManufacturingAn integrated solution for impurity and sterility analysis streamlines data, supports regulatory compliance, and uses built-in algorithms to deliver accurate, actionable results quickly.
-
![GettyImages-942424392 cell therapy]( "Raw Material Considerations For Cell Therapies")
Raw Material Considerations For Cell TherapiesFor cell therapy developers, selecting appropriate raw materials is a significant challenge. Examine key considerations for mitigating risk and aligning with current regulatory expectations.
-
![Medical scientists analyzing research-GettyImages-1413600685]( "Developing A Comprehensive Regulatory Approach For LNP Drugs")
Developing A Comprehensive Regulatory Approach For LNP DrugsThe path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.
-
![GettyImages-1357020474-digital-computer-icons-hands-business-working]( "MilliporeSigma's 97-Day Implementation Success Story")
MilliporeSigma's 97-Day Implementation Success StoryRead how MilliporeSigma transformed validation processes with a digital validation system to achieve compliance in just 97 days, as well as learn key takeaways from their swift transition.
-
Operational Readiness In Pharma9/9/2025
Operational Readiness bridges project delivery and GMP manufacturing to ensure systems and teams are prepared for execution. Discover how a digital validation platform streamlines this transition.
-
Service Solutions Designed To Help You Gain Speed To Clinic And Market4/28/2025
Discover how speed, cost, and regulatory acceptance impact drug manufacturing, as well as learn about aseptic filling challenges and how innovative services can enhance your efficiency and compliance.
-
Overcoming Challenges In Ophthalmic Formulations8/27/2025
Discover key strategies for overcoming formulation challenges in ophthalmic drug development and learn how selecting the right excipients supports quality, compliance, and safety.
-
Understanding Biotherapeutic Peptides And GLP-1 Receptor Agonists9/2/2025
Biotherapeutic peptides offer enhanced safety and efficacy over traditional drugs. Learn why rigorous impurity profiling is vital to ensure product quality, patient safety, and regulatory compliance.
-
Ensure Safety And Compliance With A Guide To Sterilization Validation5/28/2025
Sterilization validation is vital in pharma and medical device manufacturing to ensure product safety and regulatory compliance. Explore essential principles, best practices, and frameworks for effective implementation.
REGULATORY COMPLIANCE SOLUTIONS
-
![Skyland PIMS]( "Biopharma Manufacturing Process Data Made Simple")
PIMS makes BioPharma manufacturing process data accessible, transferable and meaningful
-
![GettyImages-1282633951-laptop-man-suit-office-quality-management]( "A QMS Software That Enhances Operational Excellence")
Ideagen Quality Management is a modular SaaS solution designed with the needs of quality managers in mind. Trusted by more than 6,000 customers worldwide to digitalize their quality management processes and comply with industry standards.
-
![ViralVectors]( "Cleanrooms And Equipment For Viral Vector Drug Manufacturing")
Viral vector manufacturing: key to successful gene therapy
Viral vector manufacturing, critical to the burgeoning field of gene therapy, is revolutionizing medicine with its rapid growth and significant potential for treating genetic disorders. By adhering to stringent cleanroom requirements, including BSL-2 standards, Germfree enables the safe and efficient production of viral vectors like AAV and lentivirus. Our specialized cleanroom solutions support the continued advancement of this vital therapeutic field, shaping the future of healthcare worldwide.
-
![Laptop clinical trials iStock-653839742]( "Pharmaceutical Change Control Software")
Using Document Change Control Software in Regulated Environments
Change is important in any business, but it is especially critical in life science, manufacturing, and other regulated companies, which are required to "control" change as part of compliance. This is why many companies are turning to document change control software to help them address the complexity of change control.
In regulated environments, the term "document change control" may refer to the document management or document control process, or it may to refer to the change control process, which involves rigorous documentation. Either way, most companies need document change control software to manage these processes.
-
![Axon Digidata 1550B Low-Noise Data Acquisition System plus HumSilencer]( "Axon Digidata 1550B Low-Noise Data Acquisition System Plus HumSilencer")
High-resolution, low-noise digitizer with 50/60 Hz line-frequency noise elimination.
