Transparent fees for FDA Philippines applications
Administrative, regulatory coordination, and technical dossier support — quoted per product. Official FDA charges and third-party costs are billed separately at actual cost.
Pricing basis
Professional service fees are quoted per product / application and are exclusive of official FDA fees, notarization, legalization, courier, translation, testing, product samples, and label redesign. USD conversions use a simple reference rate of ₱60 = USD 1.
Pick the level of support your filing needs
Admin Support Only
For clients who already have most required documents and need structured administrative support to organize, track, and prepare files for FDA processing.
- Prepare the FDA document checklist
- Review submitted manufacturer and supplier files
- Identify missing documents
- Organize documents into FDA-ready folders
- Prepare a file inventory tracker
- Prepare a submission-status tracker
- Rename, arrange, and format files for easier review
- Coordinate with the client regarding lacking documents
- Prepare document-request lists for the manufacturer or supplier
- Monitor document completeness before submission
- Provide administrative updates to the client or assigned representative
Admin + Regulatory Coordination
For clients who need both administrative support and regulatory coordination to align product files with FDA Philippines requirements.
Everything in Admin Support Only, plus:
- Review of product type, intended use, and application scope
- Initial coordination on whether the product may fall under CMDN or CMDR
- Product-code and presentation mapping
- Review of product variants, shades, kits, syringes, capsules, and packaging presentations
- Preparation of application-scope summary
- Review of Letter of Authorization coverage against actual product scope
- Coordination of manufacturer declarations and supporting certificates
- Review of submitted labels, IFU, packaging, and product photos for completeness
- Identification of documentation gaps before FDA submission
- Coordination support for deficiency-response requirements
- Regulatory communication support with the client, manufacturer, supplier, or distributor
Admin + Technical Dossier
For complex applications where the product file is incomplete, poorly organized, technically weak, or requires professional documentation support before FDA submission.
Everything in the two packages above, plus:
- Executive summary writing or revision
- Device description writing or enhancement
- Essential Principles conformity document support
- Risk summary preparation or remediation
- Stability, storage, packaging, and shelf-life documentation support
- Design verification & validation summary support
- Review and improvement of labeling, artworks, package inserts, and IFU content
- Review of contraindications, warnings, precautions, and adverse effects sections
- Raw material, formulation, and product specification documentation support
- Manufacturer document rewriting or restructuring
- Technical dossier gap analysis and remediation plan
- FDA deficiency-response writing support
- Submission-ready technical documentation package
Consulting / Full Advisory
High-level FDA advisory while you remain responsible for all admin work, fieldwork, filing, and execution. SealPH advises; you execute.
- FDA pathway advisory
- Product classification guidance
- CMDN vs CMDR advisory support
- Review of product scope and application strategy
- Review of manufacturer documents
- Identification of gaps in the submitted file
- Advisory on documents to request from the manufacturer
- Advisory on Letter of Authorization coverage
- Advisory on ISO/QMS certificate relevance
- Advisory on country-of-origin registration or equivalent authorization
- Review comments on labels, IFU, packaging, and product photos
- Review comments on executive summary, device description, and risk summary
- Advisory on deficiency-response strategy and FDA communication points
- Periodic consultation calls or written recommendations
What's included — and what isn't
SealPH service fees cover professional administrative, regulatory coordination, and technical documentation support only. Official FDA charges and external costs — notarization, legalization, courier, translation, testing, product samples, and label redesign — are billed separately at actual cost.