Solving your BioPharma Drug Development Challenges
Drug discovery Platform and Analytical Characterization Expertise
Development Portfolio Consulting: Drug target/disease biology evaluation and investigation.
Assay development and analytical characterization technical experts
Screening, Kinetics, Structure, instrumentation/Methods Expertise
Drug Lead: Screening, Characterization and Manufacturing
Technical consulting for drug screening platform development challenges
Process Development and manufacturing Scale-up strategies
Drug lot comparability, formulation, characterization, qualification
Drug ADMET/PK, quality and compliance
Regulatory and CMC
Drug Lead Selection and Pipeline Development Pathway Strategies
Project Managing Lead to BLA pathways
IND/BLA filings: documentation, data, authoring and review
Coaching and project management for IND module authoring, reviewing and filing
Clinical Trials & Management
Technical support for Clinical Trial management/site selection and regulatory strategy
Portfolio Analysis and Asset Valuation
Asset Valuation Models - strategic portfolio evaluation