INDs, NDAs, BLAs and global submissions.
How we help
Strategic IND, NDA and BLA authoring and submission management — with eCTD compliance and FDA / EMA scientific advice.
Category
Pharma & Biotech
Pharma & Biotech Regulatory
INDs, NDAs, BLAs and global submissions.
Representative work
DPI Inhaler
MDI Inhaler
Diagnostic instrumentation
Convenience Kits
Device classes & artefacts we support.
The problem
Drug development is a relay race between Discovery, Clinical, CMC and Regulatory. Drop the baton and you lose a year.
Our solution
Strategic IND, NDA and BLA authoring and submission management — with eCTD compliance and FDA / EMA scientific advice.
Process
How we run this engagement.
Pre-IND meeting authoring
IND CMC, nonclinical, clinical modules
Annual Product Quality Reports & safety reporting
Pre-NDA strategy and Type B and C meetings support
NDA / BLA submission
Ready to start?
Tell us about your program — we typically respond within one business day.
Book a free 30-min consult