Services

Strategic advice to Senior Management, Boards of Directors and Investors on clinical development plans

Protocol development, selection of clinical endpoints & patient populations

Development of regulatory strategy & documents

Participation in meetings with FDA and other regulatory authorities

Preparation of IND and CTA submissions

Identification and recruitment of clinical and regulatory staff

Selection, management and oversight of Contract Research Organization activities

Clinical trial oversight

Organization and participation in Data Monitoring Committee (DMC) activities

Interpretation & analysis of clinical trial results

NDA and BLA preparation; preparation for FDA advisory committees

Negotiation of pre-approval regulatory strategy & post-approval commitments

Due diligence and advice for in-licensing and merger-acquisition activities

Due diligence and interpretation of data for investors