Keep every Philippine FDA application, deadline and next move in view.
Track FDA applications, catch approaching deadlines and find your next opportunity. Practical software for Philippine regulatory teams, backed by specialist dossier consulting.
From the first status check
to the next regulatory decision.
Watch the software work.
Choose a workflow. Watch it unfold, then explore it yourself.
Interactive demos with fictional sample data. No connection to your files, the FDA or your email.
The right tool for each next step.
Four core products, Follow-up Tracker within Kiosk Monitor Pro, and specialist consulting when you need it.
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