FDA Philippines
Compliance Made Easy
Fast, reliable, and inspection-ready regulatory consulting for drugstores, drug distributors, medical device retailers, and more. We handle the paperwork — you focus on your business.
Your Dedicated Regulatory Partner
Cyril RA Assist is a Philippines-based regulatory affairs consultancy run by a licensed pharmacist and FDA compliance specialist with hands-on inspection experience across multiple FDA-regulated establishment types.
We translate complex FDA requirements into clear, actionable steps — giving you complete, accurate documents the first time, so you never face unnecessary delays or penalty fees.
Licensed Pharmacist · Regulatory Affairs Specialist
FDA Philippines Compliance Expert
End-to-End Regulatory Services
Everything you need to get licensed, stay compliant, and pass your FDA inspection — in one place.
LTO Application & Renewal
Complete, inspection-ready document packages for new LTO applications and renewals. Covers drugstores, distributors, medical devices, food, HUHS, and veterinary.
FDA Product Registration
End-to-end product registration support including CPNR, CPS, and CPR applications across drugs, cosmetics, food, and medical devices.
Inspection Preparation
FDA pre-inspection audits, gap analysis, corrective action plans, and mock inspection support to ensure your facility passes on the first try.
SOP & Document Bundles
Downloadable, ready-to-use Standard Operating Procedure templates and regulatory document bundles — customizable for your establishment type.
Compliance Ebooks & Guides
Step-by-step LTO guides for drugstores, drug distributors, and medical device retailers. Written in plain Filipino-English for business owners.
Regulatory Consultation
One-on-one consultation sessions for complex compliance questions, multi-product portfolios, or establishments transitioning to new ownership.
Built Around Your Compliance
We're not a generic consulting mill. Every deliverable is prepared by a regulatory specialist who has personally handled FDA inspections.
Fast Turnaround
Most document packages are delivered within 24-72 hours. No months-long waiting.
Inspection-Ready Accuracy
Every document is reviewed for FDA compliance before delivery. You get it right the first time.
Confidential & Trusted
Your business information stays private. We've handled over 500 client engagements with zero data breaches.
Transparent Pricing
Flat-rate packages with no hidden fees. You know exactly what you're paying before we start.
Licensed Expert Behind Every File
You're working with a licensed Registered Pharmacist — not an outsourced team.
Responsive Support
Questions before, during, and after service. We're reachable on Facebook Messenger every business day.
What Clients Are Saying
Napakadali ng proseso! Binigyan kami ng complete set ng documents para sa aming drugstore LTO renewal. Pumasa kami sa FDA inspection without any major findings. Highly recommend!
We were overwhelmed with the FDA requirements for our drug wholesale distribution license. Cyril RA Assist gave us a clear checklist, prepared our SOPs, and guided us step by step. Worth every peso.
As a veterinary product importer, FDA registration was always confusing to us. Cyril RA Assist explained everything clearly and delivered a complete registration package on time. Outstanding service.
Bought the SOP bundle for our medical device retail shop and it saved us so much time. Everything was already formatted correctly for FDA. Very professional and very responsive sa messages!
Our food supplement company needed CPR registration and we had no idea where to start. Cyril RA Assist handled the entire regulatory dossier and we got our certificate with zero deficiency. 10/10!
We were hit with an FDA notice and needed to respond in 5 days. Cyril RA Assist turned around a complete corrective action plan within 24 hours. Crisis averted. Real professionals.
Frequently Asked Questions
An LTO (License to Operate) is a mandatory permit issued by the FDA Philippines to establishments engaged in the manufacture, importation, exportation, distribution, sale, and/or use of health products. Operating without a valid LTO is a violation that can result in penalties, closure orders, and criminal liability. Every drugstore, drug distributor, medical device retailer, food business, and veterinary establishment needs one.
Processing time at FDA Philippines typically ranges from 15 to 60 working days depending on the establishment type, completeness of documents, and current FDA workload. With a properly prepared and complete application, you avoid back-and-forth with FDA that can delay your LTO by months. That's where we come in.
Core requirements include: Business Registration (SEC/DTI/CDA), Mayor's Permit, PRC license of the Pharmacist-in-Charge, floor plan, deed of lease/ownership, notarized application forms, complete SOPs for all drugstore operations, and proof of payment. Specific requirements may vary based on your establishment's scope. Our LTO bundles cover all standard requirements with ready-to-use SOP templates.
Yes. Each physical establishment location requires a separate LTO. Similarly, product registrations (CPR, CPNR, CPS) are issued per product, not per company. Multi-branch businesses need to maintain compliance for each site individually, though some supporting documents can be replicated.
FDA inspectors will review your physical premises, records management, SOP implementation, personnel qualifications, and product storage practices. Common findings include missing or unsigned SOPs, incomplete logbooks, improper temperature monitoring records, and unlicensed personnel. Our inspection prep service specifically addresses these common deficiency areas to ensure you pass.
Yes. We can help you draft a Corrective Action Plan (CAP), prepare your response to FDA's findings, and implement the necessary documentation fixes to bring your establishment back into compliance. Reach out to us immediately — FDA response deadlines are strict.
Ready to Get Inspection-Ready?
Don't let incomplete paperwork delay your business. Get a free consultation today and find out exactly what your establishment needs.