PIF Preparation & Review Service
Overview
The Product Information File (PIF) is a comprehensive, systematic, and scientifically organized technical dossier. According to the Thai Cosmetic Act and its related regulations, cosmetic notifiers (Informers) are required to establish and maintain a PIF for each product they sell, which must be readily available for inspection by the Thai FDA (TFDA) at any time.
A PIF not only serves as the ultimate proof of product compliance, but also reflects your brand’s professionalism and sense of responsibility. It functions as your product’s “legal identity record” in Thailand. Without a complete and accurate PIF, your product may face risks including rejected notifications, non-compliance during market surveillance, and potential legal penalties.
Our Services
We will help you build a professional and fully compliant PIF according to Thai regulatory requirements.
The main components include:
Basic Product & Notifier Information
Product name/brand name, formula name, notification receipt number
Detailed contact information of the notifier (Informer) and manufacturer
Product Quality & Safety Summary
The core of the PIF, summarizing product safety, efficacy, and supporting data in a concise and clear manner
Product Formulation
Complete and accurate ingredient list using INCI names, listed in descending order of concentration
Exact content or concentration ranges (in compliance with Thai restricted ingredient regulations)
Raw material specifications and Certificates of Analysis (COA)
Manufacturing Process Description
Clear explanation of the production method, process flow, and quality control points
Product Safety Assessment Report
A mandatory core requirement of the PIF
Prepared by a qualified safety assessor based on all available data, evaluating both the final product and all ingredients, and providing a conclusive report demonstrating the product is safe under normal or reasonably foreseeable conditions of use
Product Efficacy Claim Evidence (if applicable)
Scientific data supporting all label and advertising claims, such as laboratory tests, consumer sensory testing, or literature references
Examples: SPF test reports for “sunscreen” claims; moisturizing efficacy tests for “moisturizing” claims
Product Stability Test Reports
Demonstrates the physical, chemical, and microbiological stability of the product during its shelf life, providing the scientific basis for the product’s expiration date
Microbiological Test Reports
Finished product microbial limit test reports, proving compliance with hygiene standards
Packaging Material Information
Composition and properties of packaging materials, and explanation of compatibility with product contents
Adverse Event Reporting Records
System for monitoring and recording post-market adverse events related to the product
Frequently Asked Questions
What materials do I need to provide for PIF preparation?
You only need to provide product name, specifications, detailed formula, manufacturing process description, existing test reports, and manufacturer’s business license. We will provide a clear checklist for all required documents.
I don’t have a local company in Thailand. Can the PIF still be submitted?
Yes. We act as your local Thai agent, submitting the PIF under our compliant status and handling any TFDA inspections if required.
If my formula changes later, can the PIF be updated?
Yes. We will update the PIF with the new formula information and resubmit it to TFDA, ensuring the file accurately reflects the product in the market.