Leverage Expertise in Global Compliance
If desired, assistance with clinical trial applications (IND/CTA), new drug submissions (NDA/BLA/ANDA), and supplements (PAS, Type I/II) is provided. Documentation in electronic common technical document (eCTD) format is readily available to expedite regulatory filings and reviews. Regulatory services include:
- Facilitating regulatory strategy
- Facilitating interaction with regulatory authorities
- Approval on drug master files
- Guidance on regulatory submissions
- Preparing regulatory documents
- Specializing in international regulatory guidelines (FDA, EU, TGA and Health Canada)