FDA
Skill packages tagged with “FDA”
Clinical Trial Protocol (ICH E6 R3)
Draft clinical trial protocols compliant with ICH E6(R3) and ICH E8(R1). Covers study design, objectives, endpoints, eligibility criteria, estimand framework (ICH E9(R1)), statistical analysis plan, safety monitoring, IDMC, RBQMS, and regulatory submission requirements (FDA IND / EU CTR 536/2014 via CTIS) for all study phases and therapeutic areas.
Design Dossier Elaborator
Guided elaboration of design dossier, technical file, or device master record sections for medical devices: device classification, risk summary (ISO 14971:2019), essential principles (GSPR), labelling/IFU, clinical evaluation, post-market surveillance, and traceability per EU MDR 2017/745 Annex II and FDA QMSR (21 CFR Part 4).
eCTD Cross-Module Verifier
Verify consistency and data integrity of eCTD pharmaceutical dossiers. Cross-checks Module 2 (Summaries) against Module 5 (Clinical Study Reports) to ensure study references, p-values, N-counts, endpoints, and safety data are aligned before regulatory submission to FDA, EMA, or PMDA.
FDA 510(k) Premarket Notification — Substantial Equivalence Summary
Draft and validate 510(k) premarket notification submissions for Class II medical devices. Structures the document per FDA guidance (Refuse to Accept checklist, 21 CFR 807.87) with device description, predicate comparison, performance data summary, and labelling.
FDA Submission Wizard
Draft and validate FDA medical device submissions. Supports 510(k) Premarket Notifications (eSTAR format) with predicate comparison and substantial equivalence arguments, and PMA (Premarket Approval) dossiers with clinical and non-clinical data sections.
FDA Type II Drug Master File (API)
Draft and self-check Type II API Drug Master Files in FDA eCTD Module 3 format with Module 1 administrative documents, LoA, annual report, deficiency response, and completeness-assessment support.
Food Labeling & Claims (FDA / USDA)
Draft and validate U.S. food product labels and labeling claims compliant with FDA 21 CFR 101, USDA FSIS, NLEA, FALCPA, and FASTER Act. Validates required label elements, allergen declarations, nutrient content claims against nutrition data, health claims, and organic/bioengineered disclosures.
GMP SOP & Validation Author
Guided elaboration of GMP documentation — SOPs, validation protocol (IQ/OQ/PQ), and batch record template sections aligned to FDA 21 CFR 211 / EU EudraLex Vol 4 / WHO GMP.
ICH E6 Investigator Brochure (IB) Author
Author and maintain ICH E6(R3)-compliant Investigator Brochures for investigational medicinal products, including Reference Safety Information, annual update/change-control summaries, and investigator-facing risk digests aligned with FDA IND, EU CTR, CIOMS V, and ICH E2A expectations.
MDevSPICE Regulatory Readiness Narrative
Draft a regulatory readiness narrative for FDA (21 CFR 820), EU MDR, and IEC 62304; document evidence and alignment for audit or submission.
QMS CAPA Tracker
Draft and validate CAPA (Corrective and Preventive Action) reports for medical device quality management systems. Standardizes root cause analysis using 5 Whys or Fishbone (Ishikawa) methods, enforces Effectiveness Check completeness, and validates CAPA structure against ISO 13485 and FDA 21 CFR Part 820 requirements.