PHASE X BIO CONSULTING

Phase X Bio Consulting provides experienced technical consulting to the biopharmaceutical industry.

Services include scientific and technical advice on the manufacture and development of biologic pharmaceutical products:

investigational drugs to be supplied to US and overseas clinical trials
approved drug for commercial distribution in US and overseas

Specific expertise is in the manufacture of biologic molecules produced by recombinant DNA technology, including:

process engineering
process characterization and validation
analytical method development and validation
regulatory filings to US and overseas health authorities
planning and supervising contract manufacturers and contract testing labs
investigating process deviations and product nonconformance