BioPharma Consulting Services LLC (BPCS) provides high level
strategic services to small to medium sized
biotechnology and pharmaceutical companies. Services include:
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