Solutions · Regulatory & CMC
Regulatory work,grounded in the source.
Sofie searches nine health authorities and your own dossier, drafts CMC sections and responses with page-level citations, and tells you when a regulator changes something you rely on.
Researching across 9 authorities
Sources · official records
Inspection classification · Basel · NAI
fda.gov/inspections-compliance…
EudraGMDP certificate · Keller Pharma AG
eudragmdp.ema.europa.eu
Form 483 · Alameda, CA · Jun 2026
fda.gov/…/foia-electronic-reading-room
Guidance · Sterile drug products, aseptic processing
fda.gov/regulatory-information/…
SPL · establishment listing · Keller
dailymed.nlm.nih.gov
Regulatory Intelligence: official sources from nine authorities, searched, compared and cited.
Aregulatoryanswerisonlyasgoodasitsreferences.Sofiereadstheguidance,thedossierandtherecordtogether,andshowsitsworkatthepagelevel.
Work Sofie takes on
Regulatory and CMC work Sofie takes on
Prebuilt workflows that apply ICH expectations and flag missing evidence instead of guessing.
01
CMC Dossier Section (CTD)
Regulatory & CMC · Workflow
Turn your development and manufacturing data into CTD-structured Module 3 content — in an afternoon, not weeks.
Manual effort today
40+ hours across CMC, regulatory, and QA
02
Response to Questions (RTQ)
Regulatory & CMC · Workflow
Turn the authority's question letter into a response where every question and every sub-part is answered, evidenced, and reconciled against your filed dossier and everything you have already told them.
Manual effort today
Two weeks of parallel drafting across functions
03
Annual / Periodic Report
Regulatory & CMC · Workflow
Turn twelve months of change controls, stability data, labeling revisions and commitments into the periodic report your authority expects — with the period boundary held and nothing quietly absorbed that should have been filed on its own.
Manual effort today
Four to six weeks of chasing owners for what changed, rebuilding the change list from memory, and discovering during review that something in the annual report should have been a supplement filed nine months ago
04
CMC Regulatory Strategy
Regulatory & CMC · Workflow
Turn your product context, prior filings and CMC evidence into a defensible multi-market CMC regulatory strategy — sequence, established conditions, data gaps and decisions — in an afternoon, not a month of workshops.
Manual effort today
Weeks of workshops producing a slide with market columns and dates nobody can trace to data
05
Labeling / Prescribing Information (PI / SmPC)
Regulatory & CMC · Workflow
Turn a proposed change, your approved evidence and the current label into a PLR-format Prescribing Information or a QRD-compliant SmPC — every claim traced, every fact reconciled, and the filing route already identified.
Manual effort today
Weeks of circulation between regulatory, medical and CMC
06
Regulatory Designation Application
Regulatory & CMC · Workflow
Turn your evidence, your indication and the pathway you're chasing into an argument mapped one-to-one against the statute — with every criterion marked met, partially met or not met, and the gaps named.
Manual effort today
Weeks assembling an argument from memory of what the agency wants, then discovering at review that a criterion was asserted rather than evidenced
07
Drug Master File (DMF)
Regulatory & CMC · Workflow
Authors or independently reviews a US Drug Master File (DMF) — Type II (drug substance/API), Type III (packaging material), Type IV (excipient), or Type V (FDA-accepted reference information) — in CTD/ICH M4Q structure per 21 CFR 314.420.
Configured to your procedures
08
Quality Regulatory Review
Regulatory & CMC · Review
Reviews any LAUNCH Author CMC document — PTP, ATP, PDP, ADP, PDS, or ADS — against a calibrated ICH regulatory baseline, five structural and quality dimensions, and jurisdiction-specific criteria.
Estimated time saved
~8–20 hrs per review cycle
A day in the life
The same work, without the assembly.
Your experts still make every call. Sofie gathers the evidence, drafts in your format and marks what is missing.
Questions from the agency
Every sub-part answered, and checked against round one
- Before
- Questions are split by email, drafted in parallel, and a contradiction with an earlier response is caught only if someone remembers it.
- With Sofie
- Sofie breaks the request into its parts, drafts each response from the dossier and prior correspondence, and flags any conflict with earlier answers.
A guidance is revised
You hear about the change that affects you
- Before
- Someone notices the revision weeks later, then searches the portfolio by hand for what it touches.
- With Sofie
- A Sequence checks the authorities you rely on and alerts you when a relevant document is added, revised or withdrawn, with the before and after.
Annual report season
The change list is already assembled
- Before
- Owners are chased for what changed over the year, and the list is rebuilt from memory.
- With Sofie
- Sofie compiles the year's change controls and their reporting categories into a draft, and marks anything that may have needed a supplement.
“What used to take me half a day searching through guidances and cross-referencing documents, Sofie handled in seconds. The answer was there; the references were there; nothing left to chase down.”
The platform behind it
Part of one connected platform
Regulatory Intelligence
Nine authorities, cited and monitored every day.
CoDraft
Word-faithful documents Sofie drafts, redlines and cites with your team.
Sequences
Scheduled and event-triggered work that runs while you are away.
Research & Chat
Deep research across your files and the web, every claim cited.
Start with one workflow.
Measure it. Then expand.
In a working session we choose a priority workflow, define your standards and review points, and agree how to measure speed, quality and capacity. Then you evaluate Sofie's work before deciding whether to expand.