Accelerating Approvals Through Precision Submissions
Compiling watertight product registration dossiers to accelerate reviews requires art and science. Our regulatory specialists blend deep technical precision with practical agency experience having held leadership positions at organizations like the FDA, EMA, and MHRA prior to consulting.
Our dossier preparation and publishing includes:
- – NDA/ANDA/BLA/510k Compiling
- – Dossier Quality Reviews
- – eCTD Publishing and Lifecycle Management
- – IMPD and IND Folders
- – CMC and Nonclinical Data Reports
- – Clinical Evaluation Reports
- – Risk Management Plans
- – Periodic Safety Update Reports
“Valitech’s regulatory lead helped us respond swiftly to 75+ questions during FDA review to gain first-cycle approval of our novel immunotherapy.”
VP Regulatory Affairs, Enovex Therapeutics
Our submission services span:
- – Drug Registration
- – Post-Approval Change Management
- – Labeling and Advertising Reviews
- – Health Authority Meetings and Communications
- – Pharmacovigilance System Set-Up
- – Compliance Remediation Advisory
With turnkey dossiers optimized to accelerate reviews and approvals internationally, enter global markets faster while reducing regulatory risk.