Regulatory and scientific consultancy to the pharmaceutical and biotechnology industries, providing assistance with regulatory communications and compliance, strategic program planning, and technical writing and editing.
We specialize in:
- Sponsor’s authorized representative to FDA, including US Agent, for pre-approval and approved products
- CMC and regulatory writing
- Pre-IND meeting requests and data packages
- Original INDs/CTAs, amendments, CMC packages, and annual reports
- Investigator’s Brochures
- Orphan drug applications
- Original BLA and NDA submissions and amendments
- Post-approval supplements and variations
- Preparation for regulatory advice meetings with FDA and other Health Authorities, including identification of key issues for discussion, preparation of briefing documents, leading sponsor rehearsals, and participation in face-to-face meetings and teleconferences
- Due diligence, compliance, grant writing, and data presentation development
- eCTD submission preparation, including strategy and dossier lifecycle management