Regulatory Support
Our experts provide the guidance, insight, and Vetter process documentation you need to prepare a Common Technical Document (CTD) for clinical trials of your injectable drug product.
Efficiently and successfully navigating regulatory pathways is a critical step in keeping your clinical development cycle on time and on budget. In addition laying strong regulatory groundwork during your clinical trials can set your product up for even greater success at key future milestones in your product’s life cycle.
Our Regulatory Affairs team is here to provide the regulatory support to keep your product’s timelines on track – from your first clinical batches, to Phase 3 and beyond.
Take early advantage of our expertise, and your team will benefit from a smooth and proven process for managing your Common Technical Document (CTD) for clinical submissions, such as:
- Investigational New Drug Application (IND)
- Investigational Medicinal Product Dossier (IMPD)