US FDA Submission Support
The US Food and Drug Administration (FDA), through its centers for drugs (CDER) and biologics (CBER), runs one of the most demanding review processes in the world. EvySaif provides FDA submission support, preparing the eCTD dossiers and regulatory strategy behind your application, so your submission holds together as one coherent scientific argument rather than a set of disconnected documents.
- Understanding the FDA pathways
The right pathway depends on your product and evidence. An Investigational New Drug (IND) application, filed on Form FDA 1571, secures permission to begin clinical studies. To market a drug, a New Drug Application (NDA) under 505(b)(1) carries the full safety and efficacy package, while a 505(b)(2) NDA may rely in part on FDA’s prior findings or published literature, and an Abbreviated New Drug Application (ANDA) supports a generic through demonstrated bioequivalence. Biologics are submitted through a Biologics License Application (BLA). All of these are filed on Form FDA 356h, in eCTD format across Modules 1 to 5, through the Electronic Submissions Gateway. FDA now accepts eCTD v3.2.2 and the newer v4.0, and well-run programs use pre-IND and pre-NDA meetings to align with the agency before filing. Review runs to PDUFA and GDUFA timelines, after an initial filing review that checks the application is complete enough to assess.
- What we prepare
- eCTD dossiers for IND, NDA, 505(b)(2), ANDA, and BLA applications
- Module 2 summaries, clinical study reports, and integrated summaries of safety and efficacy
- Regulatory strategy: pathway selection, meeting briefing documents, and gap analysis
- Responses to FDA information requests, and complete response letter (CRL) remediation
- Labeling support and administrative forms (1571, 356h) preparation
- How EvySaif helps
We are your writing and strategy partner for FDA submissions. We author and organize the dossier to eCTD standards, advise on pathway and data strategy, and prepare your briefing documents and query responses. For sponsors without a US presence, we support the scientific and documentary side and work alongside your US agent or regulatory counsel on filing.
- Why EvySaif
As one of the best research and medical writing consultancies in India, EvySaif brings international-standard, clinician-led writing to FDA submissions at consultancy pricing. We build the dossier so its story holds together, since FDA problems are rarely formatting alone, they are usually a case that does not cohere. That coherence is exactly what we author for.
- Frequently asked questions
What is the difference between an NDA and a 505(b)(2)?
A 505(b)(1) NDA contains the sponsor's full safety and efficacy data. A 505(b)(2) NDA may rely partly on FDA's prior findings or published literature, which can shorten development for suitable products.
Is eCTD mandatory for FDA?
Yes. NDAs, ANDAs, BLAs, and commercial INDs must be submitted in eCTD format. FDA currently accepts both v3.2.2 and the newer v4.0 for new applications.
Do you file the submission with FDA?
We prepare the dossier, strategy, and forms, and support submission through your gateway account or your US regulatory counsel. We are the writing and strategy partner, not your US agent of record.