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WHITE PAPERS AND CASE STUDIES

• Revolution In The EU Pharmaceutical Legislation Ahead

  Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.

• The Smart Industry Readiness Index: A Path To Achieving Digital Maturity

  In a time defined by the Fourth Industrial Revolution (Industry 4.0), a period transforming industries through advanced technologies, the manufacturing landscape is evolving beyond something we recognize as familiar. With the potential to automate processes, enhance data visibility, optimize operations, and redefine value chains, technology is revolutionizing industries across the globe. However, many organizations grapple with a critical question: How can they assess their digital transformation (DX) readiness for this most important paradigm shift?

• Simplify CAPA In 7 Steps

  Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

• The Future Of Regulatory Operations

  The pathway to enhancing reliability, compliance, and efficiency across lifecycle management will require embracing technology and process improvement if organizations want to achieve their goals.

• GSK And Medable Discuss The Next Phase Of DCTs

  GSK and Medable share the value of embedding DCTs into strategic goals to enhance trial accessibility, diversity, and efficiency.

• Life Sciences Corporation Implements eLogbooks Across 15 Sites

  New regulations challenged how surgical kits were tracked and processed across 15 U.S. sites. Discover how one team balanced compliance and efficiency to keep life-saving procedures on schedule.

• Getting Started With Product Development Strategies

  Simplify and streamline new product development for success. Explore the importance of new product innovation, different process methods, and best practices for optimizing your company’s strengths.

• Achieving Titer Increase Up To 4-Fold While Maintaining Product Quality

  Discover customizable solutions for antibody manufacturing, as well as services for media optimization, feeding strategy optimization, and format conversion.

• Boosting CMC Regulatory Efficiency In Gene Therapy

  Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.

• Organizational Assessment For A Large MedTech Company

  Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.

• Patient Diversity: Identifying Challenges, Opportunities, And Best Practices

  By listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.

• Reducing Lead Time, Delivering >99.5% OTIF

  Explore the stocking solution offered to a mid-sized CDMO in need of a high volume of safety stock inventory to support their customer portfolio growth.