Samples / GLPI-103 / regulatory/m1/fda/FORM-356h_application_and_cover_letter.md

US NDA — Form FDA 356h, Cover Letter & Administrative Certifications — GLPI-103

Field	Value
Document ID	M1-US-356h
Version	1.0
Status	Final (mock executed)
Region	FDA (US)
Standard	21 CFR 314.50 · 314.53 · 25.31 · 54 · FD&C Act §306(k) · PDUFA
Confidentiality	Confidential — portfolio use

[MOCK — administrative identifiers fictional] An executed-style rendering of the US NDA administrative forms and submission cover letter. All names, numbers, and signatures are fictional; content is consistent with the dossier (M1-0 index; REF-002).

Change History

Version	Date	Author	Summary of Change
1.0	2026-07-05	Regulatory Affairs (US)	Initial executed-style Form FDA 356h, cover letter, and certifications

1. Submission Cover Letter

Virtual Biopharma Inc. · 100 Innovation Way, Cambridge, MA [MOCK] Date: 2026-07-05 To: U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Central Document Room.

Re: Original New Drug Application — GLPI-103 (GLP-1 / apelin [APJ] receptor dual agonist), NDA 21xxxx [MOCK].

Dear Sir/Madam, Virtual Biopharma Inc. submits this original New Drug Application under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act for GLPI-103, for the treatment of adults with type 2 diabetes mellitus inadequately controlled on metformin. The application is provided in eCTD format and cross-references IND 12xxxx [MOCK]. It contains the complete Modules 1–5, including the pivotal Phase 3 study GLPI103-301 demonstrating superiority over oral semaglutide on HbA1c at Week 52. A Pre-NDA meeting was held (MTG-PRENDA); agreements reached are reflected in this submission. The sponsor requests a standard review. Questions may be directed to the regulatory contact below. Sincerely, — [Signature] [MOCK], Head of Regulatory Affairs.

2. Form FDA 356h — Application to Market a New or Abbreviated New Drug (executed-style) `[MOCK]`

Field	Entry
Applicant	Virtual Biopharma Inc.
Product (proprietary / established name)	GLPI-103 (INN pending)
Dosage forms / strengths	Solution for injection (IV) 1/2/4 mg; oral tablet 2/4/8 mg
Route(s) of administration	Intravenous (once weekly); oral (once daily)
Proposed indication	Adjunct to diet/exercise to improve glycaemic control in adults with T2DM
Application type	Original NDA, 505(b)(1)
Cross-reference	IND 12xxxx `[MOCK]`
This application contains:	☑ Index (2.1) ☑ Labeling (M1-US USPI/Med Guide) ☑ Summary (M2) ☑ CMC (M3) ☑ Nonclinical (M4) ☑ Clinical (M5) ☑ Statistical ☑ Case report forms/tabulations (define.xml, ADaM) ☑ Patent info (314.53) ☑ Financial certification (54) ☑ User-fee cover sheet (3397)
Establishment(s)	DS synthesis, IV aseptic fill-finish, oral solid-dose sites (M3-AR §3.2.A)
Signature / title / date	[Signature] `[MOCK]` · Authorized Official · 2026-07-05

3. Companion Certifications

Financial disclosure (21 CFR 54): Form FDA 3454 (certification: no disclosable interests affecting reliability) and Form FDA 3455 (disclosure, as applicable) covering pivotal-study investigators [MOCK].
Debarment certification (FD&C Act §306(k)(1)): certification that no debarred person was used in the application [MOCK].
Environmental (21 CFR 25.31): claim of categorical exclusion; no extraordinary circumstances; Environmental Assessment not required [MOCK].
Patent & exclusivity (21 CFR 314.53): patent information and any exclusivity claims provided [MOCK].
User fee: Form FDA 3397 (PDUFA cover sheet); fee status current [MOCK].
Field copy certification: provided per requirement [MOCK].

4. Cross-References