Regulatory
PBC Biomed provides a full range of Regulatory Consulting Services from building regulatory strategies, to managing existing files and agency interactions. We support our clients by acting as an Authorised Representative and Marketing Authorisation Holder within the European Union.
Pre-Clinical / Clinical
We can help with the remediation of Clinical Evaluation Plans & drafting of Clinical Evaluation Reports, as well as conducting Clinical Evidence Gap Analysis. We also offer Biocompatibility and Patient Safety support, including the design of Biological Safety Assessments to achieve ISO 10993 compliance, auditing biological safety documentation, and managing biological testing activities with all relevant external parties.
Commercialisation
With offices in Ireland, France and the US, the PBC Biomed team works closely with clients around the world to conduct a thorough Business Opportunity Analysis on their proposed technology. We examine the market, obtain feedback from a global panel of prominent Clinical Advisors, and design robust commercialization strategies to maximise impact upon launch.