Regulatory Insights

  1. Navigating An Evolving Global Regulatory Landscape 8/19/2021

    Our regulatory experts are closely following the evolution of regulatory guidance on COVID-19 and the approach taken by global regulatory agencies.

  2. When Will Full Adherence To EU (536/2014) Be Required? 8/10/2022

    In January 2022, EU (536/2014) – a binding regulation across all members of the EU – came into effect. The new regulation will streamline procedures and remove duplication of single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirements.

  3. The Journey From File To Trial: Automating Regulatory To TMF 2/9/2021

    In this webinar, we explore the value of automation between the Trial Master File (TMF) and Regulatory solutions.  This connection can bridge the gap from the clinical trial to the regulatory filing, ensuring consistency of information while reducing duplicated data entry.

  4. Effective Way To Ensure Early Statistical Deliveries 4/7/2021

    A biopharmaceutical company had a first-in-human study in patients with solid tumors. They were in need of regular and timely reports to provied to the Safety Review Committee for dose decisions, to support rapid study completion. Cmed offered a solution by building an encapsia database to enable the sites to quickly enter their data and developed a robust and flexible set of programs to generate outputs required by the Safety Review Committee.

  5. Meridian Builds Robust Gene Therapy Research Program By Leveraging Advarra IBC Services 3/30/2021

    Partnering with Advarra’s Institutional Biosafety Committee, Meridian Clinical Research established a program for conducting clinical trials with cutting edge, genetically engineered vaccines. Download the case study.

  6. Successful Preparation Strategies For NDA/MAA Marketing Applications 4/28/2021

    No two new drug applications (NDAs) or marketing authorization applications (MAAs) are the same. Learn the key strategies that can be implemented to propel even the most complex submissions to successful regulatory conclusions.

  7. Advancing Patient Healthcare: Clarifying The 2019 Changes In India’s Drug And Clinical Trial Rules 3/29/2021

    The Ministry of Health and Family Welfare, responsible for all health policy in India, took steps to clarify their regulatory requirements and address many of sponsors’ concerns with the publication of its New Drugs and Clinical Trials Rules in 2019. With these changes, it is worthwhile for sponsors, especially biotech and specialty pharmaceutical companies, to consider the many opportunities that India and other Asia-Pacific countries offer. We have summarized some of the most significant changes in this article.

  8. Considerations To Improve Patient Outcomes In Early Drug Development 4/27/2021

    Every drug development program must begin with an understanding of how the relevant key stakeholders factor into the development process. It’s not just a matter of courtesy; a comprehensive examination of the roles played by all participants has the potential to produce faster and more concrete results, leading to improved patient outcomes.

  9. What You Can Do To Drive Collaboration Across Your TMF 2/10/2021

    Previously we had addressed why collaboration should be a key focus for organizations that want to up their TMF quality and inspection game. In this blog learn 5 steps to improve TMF collaboration and inspection readiness.

  10. Planning The Way Forward In Neurodegenerative Disease Studies 7/14/2021

    The recent FDA guidance entitled "Human Gene Therapy for Neurodegenerative Diseases" (ND) provides recommendations for Sponsors who are developing human gene therapy (GT) products for neurodegenerative diseases, which affect adult and pediatric patients. It focuses on considerations for product development, preclinical testing, clinical trial design and marketing approval pathways. This article outlines several areas to consider when preparing for regulatory agency interactions.