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