License to Operate
A License to Operate is a core FDA requirement for establishments engaged in the manufacture, importation, exportation, sale, distribution, transfer, promotion, or advertising of regulated products.
- Assess the correct LTO category based on your business activity, such as importer, distributor, wholesaler, trader, or manufacturer.
- Guide you through documentary requirements, including proof of business registration, application forms, and supporting compliance documents.
- Assist in preparing submissions for establishments handling food, food supplements, drugs, cosmetics, medical devices, and household or urban hazardous products.
- Help reduce delays by ensuring applications are properly organized before filing.
Certificate of Product Registration
A CPR is required for many regulated products, including food, food supplements, drugs, and household or urban hazardous products, before they may be lawfully marketed in the Philippines.
- Support the preparation and filing of CPR applications after confirmation of a valid LTO.
- Assist with product-specific submissions, including individual variants, dosage strengths, and packaging requirements where applicable.
- Review labels, artworks, product photographs, ingredient lists and other supporting materials for completeness and regulatory consistency.
- Help businesses manage multiple product applications in a structured and efficient manner.
- Well-prepared CPR applications improve the registration process and help businesses bring products to market with greater certainty.
Cosmetic Product Notification
Cosmetic products require notification with the FDA before they are distributed or marketed in the Philippines. This process calls for careful preparation of technical and product information.
- Assist in preparing CPN applications for businesses dealing with cosmetic products.
- Support the compilation of product formulation details, review product claims, manufacturer documents, certificates, and packaging artwork.
- Review submission documents to ensure required information is complete and consistent.
- Accurate CPN submissions help cosmetic brands enter the market while maintaining regulatory compliance.
Medical Device Registration
Medical devices and in-vitro diagnostics are subject to specific FDA requirements depending on their classification and risk category. Businesses may need to obtain a Certificate of Medical Device Notification, Certificate of Medical Device Registration, or IVDR-related approval.
- Support applications for CMDN, CMDR, and IVDR requirements, as applicable.
- Assist in preparing technical submissions, including product labels, photographs, and certificates of analysis where required.
- Help determine the correct regulatory route for medical devices and related products.
- Coordinate documentary preparation to support timely and accurate filing.
- Proper registration helps demonstrate that medical devices meet applicable standards for the Philippine market.
Renewal and Variation
FDA licenses and product authorizations are subject to validity periods and may require renewal, amendment, or variation as business circumstances change.
- Monitor validity periods for licenses, notifications, and registrations across product categories.
- Assist with renewal filings to help maintain continuity of operations and market access.
- Support major and minor variations to existing licenses or product registrations where changes must be reported.
- Help businesses remain aligned with FDA requirements as product details, ownership, or operational structures evolve.
- Ongoing regulatory support helps reduce compliance risks and avoid disruptions.
Advisory and Review
Strong preparation is essential for smooth FDA submissions. Our team provides practical regulatory support to help businesses understand requirements before filing.
- Advise on product classification and likely registration pathway based on the product type and intended activity.
- Review supporting documents for completeness, consistency, and readiness before submission.
- Assist in identifying possible gaps in documentation that may affect application timelines.
- Provide practical guidance on compliance expectations for businesses entering or expanding in the Philippine market.
