Selected papers

Robinson SA, Carter AR, Brindley DA: Bacterial Endotoxin Testing of Drugs and Biologics in the US: Ensuring Patient Safety. Regulatory Focus, 18 August 2023.

Carter AR, Brindley DA: Good Biotechnology Governance to Combat Bad Blood: Using Cautionary Tales and Storytelling to Catalyse Start-Up Success. BioProcess International, May 2022.

Robinson SA, Carter AR, Brindley DA: Expedited Regulatory Pathway Options and Utility: Pandemic to Endemic. Regulatory Focus, 7 April 2022.

Carter AR, Brindley DA: In Search of a CMO for My Biotechnology Startup: How to Navigate a Journey Without Process Maps. BioProcess International, February 2022.

Robinson SA, Carter AR, Brindley DA: The Changing Regulatory Landscape of Laboratory Developed Tests. Regulatory Focus, 30 August 2021.

Brindley DA, Meinert E, Carter AR: A Multi-Step Research Protocol for Development and Implementation of Validated Guidelines for the CMO RFI and RFP Processes: Biopharmaceutical Vendor Evaluation and Selection Minimum Standards (BioVesel). BioProcess International, December 2018.

Carter AR, Meinert E, Brindley DA: Proposing a Systematic QbD Approach Toward Validated Guidelines for CMO RFI and RFP Processes Biopharmaceutical Vendor Evaluation and Selection Minimum Standards (BioVesel). BioProcess International, October 2018.

Alturkistani A, Carter AR, Meinert E, Brindley DA: Cell Culture Media: An API or Ancillary Material? BioProcess International, September 2018.

Carter AR, Meinert E, Brindley DA: Biotechnology Governance 2.0: A Proposal for Minimum Standards in Biotechnology Corporate Governance. Rejuvenation Research, 24 August 2018.

Carter AR, Meinert E, Brindley DA: Data and Corporate Governance in Pharma and Digital Health: A Necessary Regulatory Convergence. Rejuvenation Research, August 2018.