INSIGHTS ON REGULATORY COMPLIANCE
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![GettyImages-1483243079-doctors-data-computer-analysis-tablet-office]( "Preparing Documents For Transparency And Disclosure Requirements")
Preparing Documents For Transparency And Disclosure RequirementsLearn how transparency and disclosure ensure that clinical data is accessible to the public and regulatory bodies in medical writing, which helps foster trust and accountability in the scientific community.
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![quality control business goal-GettyImages-1613839148]( "Developing Effective Procedures")
Developing Effective ProceduresEffective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.
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![GettyImages-1294339649 drug development, cleanroom]( "Top Safety Considerations In Biopharmaceutical Manufacturing")
Top Safety Considerations In Biopharmaceutical ManufacturingUnderstanding top safety concerns, from combustible material handling and chemical exposure to HPAPIs, is the first step toward preventing accidents in biopharmaceutical manufacturing environments.
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![GettyImages-1180581753-scientists-lab-monitoring-computer-laboratory]( "FAQs On The Revised EU GMP Annex 1: Volume 2")
FAQs On The Revised EU GMP Annex 1: Volume 2Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing component readiness: product, process, protection, and proof.
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Reliability Assessments And Benchmarking In Life Sciences11/7/2023
Gain insight into how a prominent medical device manufacturer observed a significant improvement in its plant-wide OSHA recordable rate and cost of goods savings of over $100,000/year in just one year.
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Compliance: Framing Success Utilizing PIC/S And EU GMP12/20/2023
Explore the differences between the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guide and the EU GMP Guides, and gain insight into the teamwork between the FDA, MHRA, and PIC/S.
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Best Practices For Internal Quality Audits In Life Sciences3/14/2025
Discover why internal quality audits are vital in the life sciences sector to ensure regulatory compliance, mitigate risks, and maintain high standards of product quality and patient safety amidst evolving challenges.
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A Mobile BSL-2 cGMP Cleanroom Delivered In Less Than 3 Weeks6/6/2024
A mobile cleanroom facility was needed for manufacturing a new monoclonal antibody product for phase 1 clinical trials. The facility had to have the ability to be repurposed for additional applications.
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Navigating GxP Compliance Challenges10/30/2024
Learn how to select and manage trusted software suppliers to streamline your digital transformation, mitigate risks, and ensure regulatory adherence. Watch to discover best practices and real-world examples.
REGULATORY COMPLIANCE SOLUTIONS
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![GettyImages-1353453774 regulations]( "Strategic Regulatory Documentation Practice")
Learn how this highly experienced and fully dedicated team is improving timeline creation complexities and management, resourcing, document interdependencies, and transmission to health authorities.
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![GettyImages-2054515915-computer-files-keyboard-digital]( "IDBS PIMS And Regulatory Compliance")
Approach for US FDA 21 CFR Part 11 electronic records and electronic signatures: IDBS PIMS has been designed, developed and tested to enable compliance to 21 CFR Part 11 to accommodate the regulatory needs of its users.
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![molecular-devices-clonepix2-mammalian-colony-picker]( "Transformative Cell Line Development Workflow ClonePix 2 Mammalian Colony Picker")
A transformative cell line development workflow with automated clone screening and optional monoclonality assurance on day 0*
The ClonePix® 2 Mammalian Colony Picker is a complete solution for the automated screening and objective selection of high-value clones across diverse cell types.
The ClonePix® 2 Mammalian Colony Picker is a fully automated system for selecting high-value clones used in antibody discovery and cell line development. Screen more clones in less time with monoclonal verification on day zero, then screen and identify for highest producers in weeks, not months.
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At Kymanox, we provide end-to-end engineering and compliance solutions for all stages of your product’s life cycle. Our Quality Engineering team utilizes a risk-based, patient-centric approach and partners with you to commercialize modern drug/biologic products, medical devices, and combination products.
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![Collaborate beside image]( "Regulatory Services Offering")
Navigating the path toward regulatory approval is a complex process. Learn how partnering with Societal™ CDMO and leveraging regulatory expertise can empower your organization to achieve its goals.
