Regustat — Regulatory Intelligence

For Philippine regulatory and business teams

Less checking by hand.
More time to move the work forward.

Five apps help you track FDA applications, prepare follow-ups, research registrations, manage GMP renewals and find medical tender opportunities.

Choose the work you need help with. Each app has a short walkthrough you can watch and try.
01 / APPLICATION TRACKING

Kiosk Monitor

For regulatory affairs teams managing many submissions.

Watch Kiosk Monitor →

Know which applications moved, without checking every DTN one by one.

Kiosk Monitor checks the applications in your tracker against the FDA kiosk. It brings changed statuses, pending files and response deadlines into one working view.

  • Catch movement. See what changed since the last check and which records need your attention.
  • Open the full record. Read the kiosk details, tracking number and status history behind an alert.
  • Decide what to do next. Review deficiency deadlines and long-pending files. Linked registry information adds competitor context for submitted products.
In a working day

Start with the applications that changed overnight, open the evidence and decide whether your team needs to respond or keep monitoring.

02 / FOLLOW-UP PREPARATION

Follow-up Tracker

For regulatory teams following up on pending applications.

Works with Kiosk MonitorWatch Follow-up Tracker →

Follow up on the right applications, at the right time.

Follow-up Tracker uses Kiosk Monitor’s movement history to identify applications that have been waiting too long. It prepares a follow-up draft with a reason for each included or excluded record.

  • Build a relevant list. Apply the follow-up schedule and waiting-time rules to the tracked applications.
  • Avoid unnecessary reminders. Hold records that moved recently, are on cooldown or need a response from your own team.
  • Review before sending. Check the email, dates and supporting evidence, then approve or veto the draft.
In a working day

An application moves before the next follow-up. Its waiting time resets, and the next draft leaves it out instead of chasing an outdated status.

03 / REGISTRY & MARKET RESEARCH

Registry Explorer

For regulatory, portfolio and business development teams.

Watch Registry Explorer →

Understand what is registered, what changed and who is active in the market.

Registry Explorer turns FDA registry information into a searchable working catalogue. Use it to investigate a product, monitor your portfolio or explore the companies behind registered products.

  • Find the right records. Combine ingredient fragments, strength, dosage form and company filters. Review supporting evidence when assessing a possible Monitored Release pathway.
  • Monitor products and changes. Review new listings, registration changes, validity dates, advisories and establishment licence movements.
  • Support a business decision. Compare competing registrations and explore manufacturer, importer and distributor links to understand who is active in the market.
For a pipeline discussion

Before pursuing a product, check the registered strengths and forms, inspect competing products and see which companies are involved. Use the supporting records to guide the next review.

Registration-pathway indications support your assessment. They are not an FDA classification or approval.

04 / MANUFACTURING SITE MONITORING

GMP Monitor

For regulatory and quality teams managing manufacturing sites.

Watch GMP Monitor →

Track the GMP application and plan the certificate renewal.

GMP Monitor brings site application progress and certificate validity into one view. A changed kiosk status and an approaching expiry are shown separately because they call for different actions.

  • Follow the application. Check status movement and open the site’s tracked DTN, kiosk header and log.
  • See renewals coming. Find certificates approaching expiry and review the relevant site details.
  • Plan the next step. Review re-inspection information and prepare renewal work with your team.
In a working day

One site has a new kiosk update. Another has a certificate nearing expiry. Open each record and handle the status review and renewal preparation separately.

05 / MEDICAL TENDER INTELLIGENCE

MedTender PH

For bids, sales and business development teams at manufacturers and distributors.

Watch MedTender PH →

Find tenders that fit what you sell, and bring evidence to the bid discussion.

MedTender PH monitors pharmaceutical and medical opportunities on PhilGEPS and matches them against your product portfolio. Historical notices and awards add context on prices, buyers and demand.

  • Shortlist relevant opportunities. Compare tender requirements with your products and see what still needs clarification.
  • Understand the commercial context. Review relevant award prices, recurring buyers, purchase frequency and regional demand.
  • Record a next step. Bring the match and evidence into a decision brief: investigate, seek clarification or pass.
For a bid discussion

A hospital in Iloilo posts a tender that may fit your portfolio. Compare the item specification, review relevant awards and decide whether to prepare a bid or ask for clarification.

Past awards provide context. They do not guarantee a winning price or replace your cost and bid review.

How they fit together

Start with the question your team needs to answer.

“What needs our attention?”

Kiosk Monitor follows applications. Follow-up Tracker uses that history to prepare reminders. GMP Monitor covers site applications and certificate renewals.

“Where should we focus next?”

Registry Explorer supports product and market research. MedTender PH connects your portfolio to procurement opportunities and award evidence.

See one task from your team’s day.

The walkthroughs use a small fictional Philippine dataset. Each shows one workflow, followed by a short task you can try.

Watch the walkthroughs →