PHARMACEUTICAL SOFTWARE & REGULATORY EXPERTISE
Regulatory intelligence.
Practical solutions.
Follow your applications, prepare the next follow-up and find the evidence behind a decision. Five connected workflows for regulatory and commercial teams.
Interactive samples. No sign-up needed.
Your applications, in view.
A clear picture of what moved today.
Your next move,
already in view.
From the application you’re waiting on to the opportunity you haven’t found yet. Choose a workflow to see it in action.
Kiosk Monitor
Check every DTN. See what moved.Batch-check your applications, spot eNODs and evaluator movements, and keep the latest status with your tracker.
Follow-up Tracker
Turn idle time into the next action.Use Kiosk Monitor’s latest logs to build follow-up lists, prepare and schedule sends, and manage replies with your team.
GMP Monitor
Every site. Every renewal in sight.Monitor manufacturing-site applications and certificate expiry dates together, so movements and renewal work stay visible.
Registry Explorer
Know your portfolio. Understand your market.Search and filter CPRs and CLIDPs instantly. Compare weekly snapshots for competitor movements, new importers and distributors.
MedTender PH
Start with your products. Find the opportunity.Screen PhilGEPS against your portfolio, account for wording variations, compare specifications and record the team’s next step.
Watch the software work.
Watch the latest product videos, then explore a sample workflow.
Videos use public registry records or fictional sample data. Interactive samples have no connection to your files, the FDA or your email.
Built for the desk that carries the whole portfolio.
One place to see what moved, what needs attention and what comes next. The Windows regulatory tools work with the tracker your team already keeps.
One morning run, not one number at a time
Every application and every site is checked before the team sits down. What moved is at the top, with the reason.
Every deadline parsed
Deficiency notices are recognised from the kiosk log and their reply deadlines counted down. Nothing lapses because nobody re-read a remark.
Follow-ups on a rhythm
Silent applications are chased on a weekly schedule with a drafted, reviewable email, and the date is stamped back into the sheet.
Your tracker stays the source of truth
The tools read the spreadsheet the team already keeps and write status back into it. No second system to maintain.
Specialist review behind the software.
The same specialists who built the software take on dossier work: pre-filing audits, deficiency responses and complex biologicals. Former health authority assessors and licensed pharmacists, under mutual NDA, at a fixed fee agreed up front.
Submission audit
A pre-filing review across the administrative, quality and clinical modules. A written report of likely deficiencies, each paired with a specific correction.
Deficiency response
Regulator-ready replies to a notice of deficiency, each point answered with the data and the justification an assessor expects to see.
Complex assets
Biologicals, biosimilars, vaccines and novel therapeutics: the full CMC and clinical picture, and a defensible pathway.
See the workflow with your own priorities in mind.
Request a guided demo and tell us what your team tracks today. We will focus the session on the applications, deadlines or opportunities that matter to you.
Prefer email? solutions@regustat.com