Circe Pharma Email Formats

Biotechnology Research • San Diego, California, United States • 1-10 Employees

Key Contact at Circe Pharma

Jaime Marach

Principal Consultant, Owner

Company overview

Headquarters	San Diego, California, United States
NAICS	541714
Keywords	Quality, Process Improvements, Analytical Science, Compendial Requirements, Regulatory Cmc Strategy
Employees	1-10

About Circe Pharma

• Spearhead analytical method development, quality control, quality assurance, manufacturing and regulatory strategy for biotech and pharma clients, enhancing science, compliance and efficiency. • Scope: early clinical phase through late clinical phase CMC strategy to support global clinical and commercial supply for patient health • Deep subject matter expertise in specification setting, compendial methods, analytical method design, fit for purpose method validation, method lifecycle management and monitoring, and IND/ANDA/NDA supportive studies (e.g., clinical in use, compatibility, shipping, equivalency, comparability, extractables/leachables, device characterization) • Identify root causes and implement continuous process improvement initiatives and efficiencies, resulting in significant reduction in unnecessary work/rework. • Design clinical phase appropriate global Regulatory CMC submission strategies, author and review regulatory submissions, ensuring high-quality documentation and timely approvals.