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 prepares 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, and the well-run programs align with the agency before they file. Every application below is submitted in eCTD format through the Electronic Submissions Gateway, and review runs to PDUFA and GDUFA timelines after an initial check that the application is complete enough to assess.
Choose the pathway
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, 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).
Build the eCTD
Applications are filed on Form FDA 356h in eCTD format across Modules 1 to 5, through the Electronic Submissions Gateway. FDA accepts eCTD v3.2.2 and the newer v4.0 for new applications.
Align with the agency before filing
Well-run programs use pre-IND and pre-NDA meetings to align with FDA on the data package and pathway before the application is submitted, so review does not begin with an argument about scope.
Clear filing review and the review clock
An initial filing review checks the application is complete enough to assess. Review then runs to PDUFA timelines for NDAs and BLAs and GDUFA timelines for ANDAs.
No US presence? 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.
What we prepare
eCTD dossiersFor IND, NDA, 505(b)(2), ANDA, and BLA applications, Modules 1 to 5.
Module 2 summariesQuality, nonclinical, and clinical summaries that carry the scientific argument.
CSRs and integrated summariesClinical study reports and integrated summaries of safety and efficacy.
Regulatory strategyPathway selection, meeting briefing documents, and gap analysis.
Query responses and CRL remediationResponses to FDA information requests and complete response letters.
Labeling and formsLabeling 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
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.
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.
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.
Have a different question?
Tell us about your product, market, and timeline, and a clinician on our team will reply with specifics rather than a sales script.
Request a proposalRegulatory submissions in other markets
Preparing an FDA submission?
Tell us about your product and timeline, and we will come back with a scoped proposal for the dossier and strategy work.
Request a proposal