Product Development & Regulatory

Our expert teams provide support through every step of development, including:

• IP evaluation and due diligence

• Developing and implementing preclinical strategies

• Developing and refining clinical strategies, development plans and operations

• Regulatory support across due-diligence, strategy development, hands on support for regulatory meetings, managing and preparing submissions including CTAs, INDs, BLAs

• Pharmaceutical development, CMC- regulatory, QA/QC and supply chain support

• Regulatory advice for companion diagnostics co-development

• Support for Regulatory interactions

• Companion diagnostics regulatory submissions

• Regulatory and development strategies across a range of therapy areas and regions

• Advice on organisational development and outsourcing key regulatory activities​​​