ANDA Writing & Filing
ANDA Regulatory Writing and Filing
Vici can deliver a fully approved ANDA filing on your behalf. We are experienced with all CMC and non-CMC aspects of ANDA writing and filing. We work with the clinic, manufacturing site or SMO, and developer (if you choose to work with your own) to ensure that your filing is approved as quickly and as cost effectively as possible.
Pre-submission Administrative Activities
- ANDA Number Request
- IIG controlled correspondence writing and submission to confirm acceptable inactive ingredients are used in the drug formulation
- Q1/Q2 Sameness controlled correspondence if applicable: Ensuring qualitative (Q1) and quantitative (Q2) sameness of inactive ingredients with the reference listed drug (RLD) to demonstrate bioequivalence for specific dosage forms.
- Packaging Changes, Batch Size Confirmation, Stability Questions: Addressing queries related to packaging modifications, verifying proposed batch sizes, and stability testing requirements.
Consultation During, Ongoing, Completed Developments and Manufacturing
We provide regulatory guidance and support during the development and manufacturing stages of the finished product to ensure compliance with regulatory requirements.
Dossier Submission in eCTD Format
Vici can prepare, review, and submit the ANDA dossier in the eCTD format – the standard format for electronic submissions to the FDA
Amendments (Query Responses) Compilation and Submission
We compile and submit responses to queries or deficiencies raised by the FDA during the review of the ANDA