Client profiles
Virtual pharma/biotech companies
Strategic advice and operational assistance
Small and mid-size US companies
Outsourcing manufacturing and preclinical testing activities; audits and project oversight
Academic labs and individual investigators
Interacting with regulatory agencies, responding to queries, documentation support
Some of our projects
Managed transfer to India for all CMC activities for an NCE molecule for virtual company with an US IND; submitted IND amendments
Compiled investigator IND and IMPD for EU submissions
Provided continuing oversight for Phase III API manufacturing campaign in India
Audited multiple API and drug product facilities for different types of API and drug products
Trained preclinical CRO in preparing for GLP-compliant TK analysis and reporting
Completed two customized on-site training programs for regulatory affairs department of major pharmaceutical company located in Hyderabad, India
