RCA Radio

Regulatory Compliance Associates
RCA Radio

RCA Radio covers the latest news and challenges in regulatory, compliance, and quality assurance facing the medical device, pharmaceutical, and biologic industries. In each episode, join Regulatory Compliance Associates® (RCA) and industry thought leaders as we navigate the issues that matter to you most.

  1. JAN 22

    2025 Pharmaceutical Outlook

    In this episode of RCA Radio®, host Brandon Miller is joined by Anita Michael, Executive Pharma Compliance Expert & Principal Consultant and Rona LeBlanc-Rivera, Director, Regulatory Affairs both at Regulatory Compliance Associates®.  We explore possible changes in the Pharmaceutical industry in 2025 and provide you with insight on how to prepare yourself for these upcoming initiatives. Listen in as we go over the expected reduction in the FDA's work force, recently executed guidance documents, regulatory timelines, drug labeling transparency, the broadening scope of OTC products, the use of AI in the regulatory review, and how companies can use 3rd party inspections to help prepare themselves. About RCA Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges: PharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory, compliance, quality, and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

    17 min
  2. 12/19/2023

    Global Regulatory Standards

    In this episode of RCA Radio, host Brandon Miller is joined by Jordan Elder, Regulatory Compliance Associates'® (RCA) Regulatory Expert. Kinga Demetriou, an Expert Certifier at BSI, and Nathan Shipley, a Global Certification Manager at BSI to discuss the current trends and challenges with Regulatory Requirements US and EU while focusing on personal protective equipment. Listen in as we cover the current trends in the industry, the challenges companies face in relation to the trends, and how companies can address and prepare in this evolving landscape. We cover things like market access, product category changes, as well audience diversification with personal protective equipment (PPE), and why the regulatory requirements are changing in these areas.   About BSI BSI enables people and organizations to perform better. They share knowledge, innovation and best practice to make excellence a habit – all over the world, every day. Their solutions and services improve performance and support the United Nations Sustainable Development Goals. At BSI, our mission is to share knowledge, innovation and best practice to help people and organizations make excellence a habit. This is underpinned by our role as the national standards body and through our prestigious Royal Charter.   About Regulatory Compliance Associates Regulatory Compliance Associates (RCA) provides regulatory compliance consulting to the following industries: Life SciencesPharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceLab TestingWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. Our life science consultants are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience. Founded in 2000Expertise backed by over 500 industry subject matter expertsAcquired by Sotera Health in 2021

    23 min
  3. 01/25/2023

    2023 Industry Outlook - Pharmaceutical

    In this episode of RCA Radio, host Brandon Miller, Steve Lynn, and Susan Schniepp explore what is happening in the Pharmaceutical industry in 2023 and provide you with insight on how to prepare yourself for these upcoming initiatives. Steve is Regulatory Compliance Associates®  (RCA) Executive Pharmaceutical Consultant and Susan is the chair of PDA and as well as a Distinguished Fellow at RCA.  Listen in as we go over the increase in spending in the industry as a whole, the continued expansion of cell and gene therapies, drug and device combination products for home and office use, cybersecurity in combination products, non-life science company’s getting into the pharma industry, data integrity and compliance issues, vaccine development with the expansion of mRNA technologies, the post pandemic shift of 503b compounders, and finally the cultural shift around retiring.  About RCA Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges: PharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceWe understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory, compliance, quality, and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

    26 min

Ratings & Reviews

5
out of 5
11 Ratings

About

RCA Radio covers the latest news and challenges in regulatory, compliance, and quality assurance facing the medical device, pharmaceutical, and biologic industries. In each episode, join Regulatory Compliance Associates® (RCA) and industry thought leaders as we navigate the issues that matter to you most.

To listen to explicit episodes, sign in.

Stay up to date with this show

Sign in or sign up to follow shows, save episodes, and get the latest updates.

Select a country or region

Africa, Middle East, and India

Asia Pacific

Europe

Latin America and the Caribbean

The United States and Canada