Philippine FDA regulatory dossier consulting, read like an assessor.
The software exists because our reviewers needed it. The same reviewers, former health authority assessors and licensed pharmacists, take on submissions: pre-filing audits, deficiency responses and complex assets, section by section against the guideline that governs it. Every engagement is scoped and priced before work begins, under mutual NDA and an encrypted data room.
Audit, respond, or map the pathway.
Pick the one that matches where the submission stands. If you are not sure, the first call is free and no documents are needed to have it.
Submission audit
A structured pre-filing review across the administrative, quality and clinical modules. You receive a written report of likely deficiencies, each paired with a specific correction, so the dossier clears intake without friction. Best before filing, or before a resubmission.
Deficiency response
When a notice of deficiency arrives, the reply decides whether you are approved or sent back a cycle. We prepare regulator-ready responses that answer each point with the data and the justification an assessor expects, and check that every document in the package agrees with every other.
Complex assets
Biologicals, biosimilars, vaccines and novel therapeutics carry a heavier evidentiary burden. We review the full CMC and clinical picture and map a defensible pathway for your most demanding products, including comparability and Part III and IV strategy.
Where the software helps
Consulting clients get the products at work on their own submissions: VP Crawler for classification and competitor context, Kiosk Monitor for the application after filing. Ask about a combined engagement.
From first call to deliverable.
Four steps, in this order, every time.
Consultation
You describe the product, market and where the submission stands. Confidential, and no documents needed to talk.
Mutual NDA
Signed before anything changes hands. A private encrypted data room is then opened for your files.
Review
The submission is assessed section by section against ICH, ASEAN and the relevant national requirements.
Deliverable
A written findings report or a full response package, at the fixed fee agreed up front.
Who does the review?
Reviewers with health authority assessment experience and licensed pharmacists with dossier experience. You meet the reviewer on the first call.
How is the fee set?
By the scope agreed after the consultation: the number of modules, the dosage form, and whether it is a first filing or a response. It is fixed before work begins and does not change unless the scope does.
How fast is a deficiency response?
It depends on the number and depth of the deficiencies. Most responses are scoped on the first call with a delivery date that leaves time for your internal review before the compliance deadline.
Do you cover markets outside the Philippines?
Yes. ASEAN and GCC filings in ACTD, CTD and eCTD formats. National requirements are checked against the current guidance of each authority.
Find the gaps before your assessor does.
A short, non-confidential description is enough to start. We reply within two working days with a scope and a fixed fee.
Prefer email? solutions@regustat.com