Accelerating Medical Innovation
To Enhance Patient Wellbeing
Explore Our Consultancy Services
Many MedTech companies are choosing to outsource their ‘non-core’ business activities on account of capacity limitations or budget issues, or because they do not have the expertise or skillset in-house. PBC Biomed offers Regulatory, Clinical, Quality Assurance and Commercial support, to promote compliance and to accelerate commercialisation in today’s fast-changing medical marketplace
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.
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.
Accelerating Medical Innovation – AIM
Our Innovation Management Tool ‘AIM’ allows us to partner with clients on taking an idea from concept to commercialisation quickly, while de-risking potential roadblocks along the pathway to success. Whether you need a partner for a specific step or the entire journey, we can help.