Complete Regulatory Solutions for Every Establishment
From initial LTO applications to FDA product registration and inspection preparation — we handle every step of your regulatory journey.
LTO Application & Renewal
The License to Operate is the foundation of your FDA compliance. Whether you're opening a new establishment or renewing an existing license, incomplete documents are the #1 reason for delays and rejections.
Establishment Types Covered
Our Process
Free Assessment
Tell us your establishment type and current status. We'll identify exactly what documents you need and flag any compliance gaps.
Document Preparation
We prepare or review your complete LTO package — SOPs, application forms, floor plans, annexes — formatted to FDA standards.
Quality Review
Every document undergoes a final compliance check before we deliver. No template left unfilled, no requirement overlooked.
Submission & Follow-Up
We guide you through the submission process and stay available for any queries from FDA until your LTO is released.
FDA Product Registration
Before any regulated product can be sold in the Philippines, it must be registered with the FDA. Our product registration service covers the preparation of complete regulatory dossiers — saving you months of trial and error.
Product Categories Covered
Pharmaceutical Drugs
Prescription and OTC drug products
Cosmetics
Skin care, hair care, personal care
Food & Food Supplements
Processed foods, nutraceuticals, health supplements
Medical Devices
Class A, B, C, D medical devices
Product Classification
Determine FDA center, registration pathway (CPR/CPNR/CPS), and applicable guidelines for your product.
Dossier Preparation
Compile and format all technical, administrative, and safety documents in the required FDA or CTD format.
Label Review
Review all labeling elements for compliance with FDA labeling requirements and general food/drug labeling standards.
Submission & Tracking
Submit through the FDA ePortal and track application status until approval. Respond to any FDA queries promptly.
Pass Your FDA Inspection
An unannounced FDA inspection can catch even compliant businesses off guard. Our inspection prep service ensures your facility, records, and personnel are ready at any moment.
Common Inspection Findings We Prevent
Missing or Unsigned SOPs
The #1 deficiency. We ensure every required SOP is present, signed, and implemented.
Incomplete Logbooks & Records
Temperature logs, dispensing records, inventory logs — we set up and verify all required recordkeeping.
Expired or Invalid Licenses
We audit all professional and establishment licenses for validity and flag upcoming renewals.
Non-Compliant Storage Conditions
Cold chain, controlled substances, hazardous materials — proper segregation and monitoring protocols.
Document Audit
We review all your current documents, licenses, and SOPs against FDA inspection criteria.
Gap Report Delivery
Receive a prioritized list of deficiencies with specific remediation steps for each item.
Remediation Support
We help you prepare, update, or create the required documents and train personnel on proper implementation.
SOP & Document Bundles
Ready-to-use, professionally formatted SOP and document bundles for the most common FDA-regulated establishment types. Instant download. Fully editable. Backed by real FDA compliance experience.
Available Bundle Types
Community Drugstore Bundle
BestsellerComplete SOP set, logbook templates, dispensing records, temperature monitoring forms, and LTO checklist for retail pharmacy operations.
Drug Distributor / Warehouse Bundle
Wholesale/distribution SOPs, receipt and issuance procedures, warehouse control documents, and Risk Management Plan template.
Medical Device Retailer Bundle
NewComplete LTO and SOP package for CDRR-registered medical device retail establishments, including Class A-D device handling protocols.
Not Sure Which Service You Need?
Send us a message and describe your establishment. We'll tell you exactly what you need — for free.