Regulatory Solutions

  1. Clinical Quality Assurance And Compliance Oversight 9/26/2023

    Explore this tailored assessment and support offerings in clinical quality assurance (CQA) compliance, designed to safeguard adherence to relevant regulations and good clinical practice (GCP).

  2. Making The Impossible Possible In Oncology And Hematology Clinical Development 9/20/2023

    When the complexities of designing and executing cancer trials in a highly competitive market can mean delays in delivering urgently needed treatments to patients, it pays to have a trusted partner by your side.

  3. Get Phase-Appropriate CMC Support 9/20/2023

    Strategic product development and CMC regulatory planning start early on at the pre-IND stage and apply to the entire development lifecycle through to post-approval.

  4. How To Achieve Timely Migration Of Your TMF 9/18/2023

    This precise, proven methodology delivers a high-quality migration of your Trial Master File to the destination system, typically just 4-6 weeks after receiving all documents from the source system.

  5. FDA & ex-U.S. Product Approval 8/2/2023

    Trial protocol strategies for FDA approval must also meet the needs of global regulators, if a therapy is to be commercialized worldwide. Michael Krams, chief quantitative medicine officer at Exscientia explains how R&D leaders should think about FDA and ex-U.S. product approval.

  6. Phase 2 Clinical Trials: What to Include (And What To Leave Out) 8/2/2023

    How do drug developers make decisions about what to include, and what to leave out, of a Phase 2 clinical trial? Mitchell Katz, SVP, global clinical operations at Kyowa Kirin discusses collecting competitive intelligence and forging relationships with regulators.

  7. Solutions For Health Authority Inspection Readiness And Remediation 7/26/2023

    Unearth how Advarra identifies proactive solutions to minimize noncompliance risk, prepares teams for regulatory inspections, and provides competency for FDA and EMA inspection readiness.

  8. Frozen Packaging Solutions 6/21/2023

    Delve into how this partner's scalable packaging services for logistics support can achieve higher operational efficiency and lower quality and safety risks.

  9. Drug Accountability And Returns Management 6/8/2023

    See how sponsors are using electronic solutions for Drug Accountability (DA) and experiencing significant increases in efficiency and accuracy that these methods provide.

  10. End-To-End Safety Solutions Designed For Success 6/6/2023

    As one of the world’s largest and most experienced safety and PV organizations, unearth how this provider is bringing extensive expertise and regulatory intelligence to every industry engagement.