CONSULTING IN RESEARCH & DEVELOPMENT FOR 

BIOTECH, PHARMA, AND MEDTECH 

Cross-Industry Support: Versatile in providing strategic and technical support across various sectors, including startups, biotechs, pharmaceutical companies, and investment firms.

High-Value Clinical Data Packages: Proven track record in delivering comprehensive and high-quality clinical data packages that support successful drug development and regulatory submissions.

Early to Late-Stage Drug Development: Extensive experience navigating all phases of drug development, from initial research and preclinical studies to late-stage clinical trials and regulatory approval.

Clinical Trial Design and Execution: Provide guidance on designing trials across all phases (Phase 1 to 3) while adhering to good clinical practice. Develop and review study protocols to ensure they meet regulatory requirements and scientific objectives. Navigate regulatory landscape, from IND to NDAs/BLAs and other relevant filings (e.g. BTD, ODD, PIP, PSP, Briefing Books).

Strategic Product Development: Providing expertise on developing new therapies leveraging strategic development and extensive therapeutic experience. Ensuring success by preparing market application and planning lifecycle management to advance from early-phase trials and increase the likelihood of achieving commercial success. 

Pipeline Development: Develop strategies for advancing drug candidates through the development pipeline, including identifying key milestones and potential risks.

Business Development & Licensing: Assessing early and late stage assets for business development and licensing deals.

Board Positions: Provide valuable support working closely with management and stakeholders to support the company through various stages of development.