Life Sciences - Regulatory

Capabilities & Skills

Advertising and Promotion

Advisory Committee Participant/Panelist

Briefing Documents for Regulatory Authorities

Clinical Development

CMC Regulatory – Large Molecules

CMC Regulatory – Small Molecules

HDEs

IDEs

Pre-IND

INDs

Labeling

Operations

Orphan Drug/Biologics

Quality Assurance

Regulatory Strategy

Regulatory Plans for Clinical Development

Special Safety Submissions (e.g., REMS, Risk Management Plans)

Submissions to Achieve Marketing Approval

TPPs

Product Recalls

Safety/Pharmacovigilance

Benefit-Risk Assessments