IND
IND submission software for Module 1-3 drafting, clinical hold response planning, and cross-functional readiness tracking. Keep CMC, nonclinical, and clinical work aligned before filing.
Submissions
Workflow Templates by Submission Type
Choose a structured workflow model for FDA IND, NDA, BLA, ANDA, 510(k), De Novo, and PMA filings, Health Canada CTA, NDS, ANDS, SNDS, and post-NOC changes, EMA MAAs, variations, renewals, and line extensions, and MFDS, PMDA, and TGA submissions, across authoring, publishing, validation, and remediation.
NDA
NDA submission software for supplement management, cross-functional readiness, and eCTD validation. Coordinate CMC, clinical, and labeling work so the package stays aligned through filing.
BLA
BLA submission software for CMC dependency tracking, evidence coordination, and review readiness. Keep clinical and manufacturing changes aligned as the package evolves.
ANDA
ANDA submission software for bioequivalence tracking, labeling alignment, and deficiency-response routing. Keep repeatable workflows in place across product lines and GDUFA timelines.
510(k)
510(k) submission software for predicate mapping, evidence assembly, and submission readiness. Keep testing, labeling, and substantial-equivalence arguments aligned so review questions do not slow clearance.
De Novo
De Novo submission software for evidence planning, risk-control traceability, and cross-functional execution. Coordinate novel-device arguments, testing, and clinical inputs so the classification request is easier to defend.
PMA
PMA submission software for Class III devices: organize clinical evidence, manufacturing information, and the substantial body of valid scientific evidence FDA expects, so a premarket approval stays coordinated through panel review and approval.
Health Canada
Health Canada eCTD submission software that builds the Canadian Module 1, checks it against Health Canada's schema, and validates each v3.2.2 sequence against Health Canada's published eCTD validation rules.
EMA
EU eCTD submission software for the European Medicines Agency centralised procedure. Build the EU Module 1 and validate v3.2.2 and v4.0 sequences against the EU eCTD validation criteria.
MFDS
MFDS submission support for teams filing with the Ministry of Food and Drug Safety (MFDS), Republic of Korea, in the same Assyro workspace as their FDA, Health Canada, and EMA submissions.
PMDA
PMDA submission support for teams filing with the Pharmaceuticals and Medical Devices Agency (PMDA), Japan, in the same Assyro workspace as their FDA, Health Canada, and EMA submissions.
TGA
TGA submission support for teams filing with the Therapeutic Goods Administration (TGA), Australia, in the same Assyro workspace as their FDA, Health Canada, and EMA submissions.
CTA
Clinical Trial Application (CTA) software for Health Canada eCTD filings. Keep a protocol's Pre-CTA, CTA, and CTA amendments in one dossier and validate every sequence before you file.
NDS
New Drug Submission (NDS) software for Health Canada. Build each NDS sequence in eCTD v3.2.2 with the Canadian Module 1 and validate it against Health Canada's eCTD rules before you file.
ANDS
Abbreviated New Drug Submission (ANDS) software for Health Canada generic filings. Build each ANDS sequence in eCTD v3.2.2 with the Canadian Module 1 and validate it before you file.
SNDS
Supplemental New Drug Submission (SNDS) software for Health Canada. Build SNDS, SNDS-C, and SANDS sequences in eCTD v3.2.2 and validate them against Health Canada's eCTD rules.
Post-NOC Changes
Post-NOC change software for Health Canada. Build Notifiable Change, Level III, and supplement sequences in eCTD v3.2.2 and validate them against Health Canada's eCTD rules.
MAA
Marketing Authorization Application (MAA) software for the EMA centralised procedure. Build the EU Module 1, validate against the EU eCTD criteria, and file in eCTD v3.2.2 or start in v4.0.
Type IA/IB Variations
Type IA and IB variation software for centrally authorised products. Build each variation sequence with the EU Module 1 envelope and validate it against the EU eCTD criteria before you file.
Type II Variations
Type II variation software for centrally authorised products. Build each major variation sequence with the EU Module 1 envelope and validate it against the EU eCTD criteria before you file.
EMA Renewals
Renewal software for centrally authorised products. Build the renewal sequence with the EU Module 1 envelope and validate it against the EU eCTD criteria before you file.
EMA Line Extensions
Line extension software for centrally authorised products. Build the extension sequence with the EU Module 1 envelope and validate it against the EU eCTD criteria before you file.
Guides for your next decision
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