Regulatory Solutions

  1. Preparing Regulatory Marketing Applications For Successful Conclusions 9/27/2023

    Preparing regulatory marketing applications to their successful conclusions is our focus.

  2. Risk-Based Monitoring 9/26/2023

    Program, country, and study managers, CRAs, clinical monitors, trial managers, clinical data managers, CROs, and others need informatics solutions that help them focus on sites in greatest need, based on risk.

  3. GMP Auditing, Compliance, And Specialized Consulting 9/26/2023

    Ready to make your research altogether better? Learn how Advarra® is assisting clients to reduce risk and ensure adherence to good manufacturing practice (GMP), good laboratory practice (GLP), and good tissue practice (GTP) standards.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.