NutriPureCase study
Imported Food Supplement
First-time importer needed CPR for a multivitamin line with complex foreign documentation.
CPR approved in 92 days
Before
Day 0 — Dossier intake
After
Day 92 — Market-ready
3 SKUs cleared →
FDA PHILIPPINES — ADMINISTRATIVE ASSISTANCE
Get your products FDA-approved in the Philippines — without the paperwork chaos.
We handle the full FDA process for local and foreign companies — LTO, CPR, CMDN/CMDR, IVDR, and CPN — so you can focus on bringing your product to market.
- End-to-end FDA filings
- Local & foreign entities
- Renewals & variations
- Compliance audits
Trusted by 200+ brands filing with the Philippine FDA
NutriPureMediCoreLumièreVitaLabAurora HealthBotanikaPH
Our Services
Every FDA filing, handled end-to-end
From your first License to Operate to renewal cycles years later, we manage the documentation, submissions, and follow-ups with the Philippine FDA.
License to Operate (LTO)
Required certification for importers, distributors, wholesalers, and manufacturers of regulated health products.
Certificate of Product Registration
CPR filings for drugs, food, food supplements, and household/urban hazardous products.
Medical Devices (CMDN / CMDR / IVDR)
Notification and registration for medical devices and in-vitro diagnostic devices across all risk classes.
Cosmetic Product Notification
CPN filings for local and imported cosmetic products, including formulation and labelling review.
Variations & Amendments
Major and minor variations of LTO and product registrations for drugs, food, and medical devices.
Renewals & Compliance
Permit renewals and facility compliance with FDA specifications for production and storage.
Client stories
Loved by founders and regulatory teams
From local startups to multinational entrants — here's what clients say about working with SealPH.
"SealPH took our CPR filing from a paperwork nightmare to a clear, weekly checklist. We launched our supplement line three months ahead of schedule."
Maria Santos
Founder & CEO
500+
FDA filings processed
12+
Years of regulatory experience
98%
First-pass approval rate
24h
Response time on inquiries
Case studies
Real filings. Real timelines. Real outcomes.
A snapshot of recent client engagements — from intake to FDA approval.
LumièreCase study
Cosmetic Product Line (CPN)
French skincare brand entering PH with 12 SKUs requiring label and formulation review.
12 CPNs filed in 6 weeks
Before
Week 0 — Label audit
After
Week 6 — All notified
Zero resubmissions →
Aurora HealthCase study
Class B Medical Device (CMDR)
Local distributor needed LTO and CMDR for diagnostic equipment with tight launch deadline.
LTO + CMDR in 110 days
Before
Day 0 — Facility prep
After
Day 110 — Cleared to sell
Launched on schedule →
Approved products
Products we've helped get FDA-cleared
A glimpse of cosmetics, supplements, drugs, and devices our team has guided through Philippine FDA registration.
← Scroll to explore →
- FDA CPN
CosmeticHydrating SerumLumière - FDA CPR
Food SupplementDaily MultivitaminNutriPure - FDA CMDR
Medical DeviceClass B Diagnostic KitAurora Health - FDA CPN
CosmeticRestorative LotionBotanikaPH - FDA CPR + LTO
Drug ProductPain Relief TabletsMediCore - FDA IVDR
In-Vitro DiagnosticRapid IVD Test KitVitaLab
How we work
A clear path from application to approval
A structured, transparent process — you always know what's next and what the FDA needs from you.
01
Discovery & Classification
We assess your product, classify it under FDA categories, and map the required licenses and registrations.
02
Document Preparation
Our consultants prepare application forms, technical dossiers, labels, and supporting documents.
03
Filing & Follow-up
We file with the FDA eServices portal, pay fees, and actively follow up until issuance.
04
Approval & Renewals
We deliver your certificates and track validity to handle renewals and variations on time.
About us
Your local FDA partner in the Philippines
We are a Manila-based regulatory consultancy specializing in FDA administrative assistance. Our team works alongside domestic businesses and foreign entities entering the Philippine market — managing every form, signature, and follow-up so your product gets approved faster.
- Filipino-led team with deep FDA Philippines expertise
- Pharmacist-assisted review of labels, IFUs, and technical files
- Trusted by local startups and multinational brands
- Bilingual support in English and Filipino
- Transparent pricing and timelines, no hidden fees
New — Pharmacist-Assisted Review
Now with a licensed pharmacist partner on every file
SealPH provides FDA Philippines administrative, regulatory coordination, and technical dossier support for health products — now strengthened with pharmacist-assisted review of product documentation, labeling, safety information, technical files, and compliance readiness.
PRC-registered pharmacist partner
Registered since 24 March 2017 · PIC validity until 19 March 2029. Verified via the PRC online verification system.
Important boundary: Our pharmacist partner strengthens technical review, but does not automatically act as your FDA Authorized or Qualified Person. Official FDA account ownership, submission, and the appointment of the Authorized or Qualified Person remain with the client's FDA-licensed establishment, in accordance with FDA rules.
Product classification support
Pharmacist-assisted review of whether your product is a drug, medical device, cosmetic, food supplement, or other FDA-regulated health product.
Label, IFU & claims review
Checks of labels, directions for use, warnings, storage conditions, and safety statements before submission.
Technical gap assessment
Identification of weak or missing documents — formulation, certificates, stability data, safety files, and manufacturer declarations.
Deficiency response preparation
Pharmacist-level technical checking on draft responses to FDA clarifications before they go to the client or manufacturer.
Compliance disclaimer
SealPH is not FDA-licensed and not FDA-accredited. We provide administrative, regulatory coordination, pharmacist-assisted compliance review, and technical dossier support only. The official FDA account, submission, and the role of the Authorized or Qualified Person remain with the client's FDA-licensed establishment, in accordance with FDA Philippines rules.
Book a review call
Request a pharmacist-assisted review call
Tell us about your product, your target timeline, and how complete your documents are. We'll schedule a short call to walk through your FDA pathway and where pharmacist-assisted review will add the most value.
- • Free 30-minute discovery call
- • Pharmacist-assisted document gap check
- • Clear scope, timeline, and quote within 1 business day
In their own words
Hear from the founders we've helped
Short conversations with founders and regulatory leads about their FDA journey with SealPH.
Wall of love
Notes, emails & shout-outs from clients
The unfiltered version — quick quotes, thank-you emails, and LinkedIn recommendations from teams we've helped get approved.
Client note
"Honestly the smoothest CPR experience we've had in 8 years of importing."
Carla M.
Operations, NutriPure
LinkedIn recommendation
"Highly recommend SealPH. They turned what we thought was a 9-month process into 3 months. Detail-obsessed and responsive."
Ramon Dela Cruz
Regulatory Affairs Manager
Client email
"Just got the approval email from FDA — couldn't have done it without your team. Thank you for the relentless follow-ups!"
Hana L.
Lumière Cosmetics
Client note
"They speak FDA so we don't have to."
Antonio R.
Aurora Health
LinkedIn recommendation
"If you're a foreign brand entering the Philippines, start with SealPH. They saved us from three potential resubmissions."
Priya N.
APAC GM, BotanikaPH
Client note
"Transparent pricing, no surprises, and our LTO renewal was done before the old one expired."
Jess T.
VitaLab
Client email
"Approval came in this morning 🎉 You made our launch happen. Forever grateful!"
Mika S.
MediCore
Client note
"Felt like having an in-house regulatory team without the overhead."
David O.
Founder, Aurora Health
FAQ
Common questions about FDA registration
Still unsure? Send us your product details and we'll map your exact FDA pathway.
Compliance disclaimer
SealPH is not FDA-licensed and not FDA-accredited. We provide administrative, regulatory coordination, pharmacist-assisted compliance review, and technical dossier support only. The official FDA account, submission, and the role of the Authorized or Qualified Person remain with the client's FDA-licensed establishment, in accordance with FDA Philippines rules.
Get started
Let's secure your FDA license & permits
Tell us about your product. We'll respond within one business day with a clear scope, timeline, and quote.
hello@sealph.com
+63 917 152 9010
SealPH Inc., 9/F Filinvest One Bldg, Northgate Cyberzone, Northgate Ave, Alabang-Zapote Road, Muntinlupa 1781
28th Floor, The Enterprise Center Tower 2, Paseo de Roxas, 6766 Ayala Ave, San Lorenzo, Makati City 1226