Regulatory Affairs

Unique and Strategic Regulatory Pathway to Market for CDMO Clients and Pipeline Biosimilars

Regulatory Submissions

We have an internationally experienced team to lead CMC regulatory submissions for clients with many successful IND/CTA filings globally. Our goal is to save our clients valuable time and costs by providing hassle-free communication/responses and a deep understanding of the requirements for all phases of regulatory and clinical development.

Regulatory Communication

Along with providing a well-versed Regulatory Submission service for our clients, we can support regional Health Authority consultations & strategic planning, initiate Pre-IND and Scientific Advisory Meetings, and provide written support for the CMC sections of all types of dossiers.

Regulatory Strategy

We have established a close working relationship with agencies in EU, US, Australia, China, India and other Asian countries, with proven success in receiving approvals for PK/PD Clinical Trial Applications AND leading Phase I to III Safety & Efficacy Clinical Trials.

Eden-Regulatory Affairs Experience
Contact us to learn more!