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Life Sciences Compliance Services in the Philippines
Philippines-based company offering regulatory support, approval strategy, and compliance consulting for life sciences sectors.
Philippines
Local Consulting for Regulatory Needs in the Philippines
Philippine market provides huge opportunities for enhancement of Lifesciences products. This facilitates manufacturers of Lifesciences product to thrive and expand with excellence in Philippines market.
Artixio as the trusted regulatory partner in Philippines helps in 100% regulatory compliance with the FDA Philippines. We focus on resolving regulatory concerns directly with the FDA Philippines for a hassle-free product approval and seamless regulatory process. Over the years we have supported products in Philippines with our experienced local professional in Philippines. We are committed in providing remarkable services to navigate through the challenges in Philippine compliance.
Regulatory Authorities in Philippines
The main regulatory authority governing in Philippines is the Food and Drug Administration (FDA) Philippines which was earlier known as the Bureau of Foods and Drugs. The FDA Philippines works under the Department of Health. Some other regulatory authorities are working too, such as Hong Kong’s Centre for Food Safety (CFS) which operates under the Hong Kong Food and Environmental Hygiene Department (FEHD) for regulation of beauty products and cosmetics, and the Bureau of Animal Industry (BAI) under the Philippine Department of Agriculture which regulates animal care and veterinary products.
The following table depicts the regulatory bodies responsible for which category of products:
| Industry | Regulatory Body | Responsibilities |
|---|---|---|
| Pharmaceuticals | FDA (Philippines) | Grants drug approval and market access. Ensures safety and efficacy of drug. |
| Medical Devices | FDA (Philippines) | Regulates the Medical devices in the Philippian market. |
| Wellness products | CFS | Confirms the quality and ensures the safety and efficacy of wellness products. |
| Cosmetics | FDA (Philippines) | Ensures the quality, standards, purity of cosmetics in Philippian market. |
| Animal care and Veterinary products | BAI | Regulates the veterinary products in the Philippian market by confirming its safety, efficacy and quality. |
Ensure Seamless Regulatory Compliance in the Philippines with Artixio
Registration Compliance Process and Submission Preparation
Service Category
- Regulatory Affairs
- Market access
- Pharmaco-vigilance
- Quality Assurance
Pre-registration services
- Regulatory Intelligence
- Market assessment
- Technical and medical writing
- Local Agent Appointment
- Document Review
- Risk Management
- Pre-submission to FDA (Philippines)
- IND
- NDA
- Dossier Gap Analysis
- Technical Due Diligence
Registration services
- Product registration in Philippines
- Submission of registered documents
- to FDA (Philippines)
- HA liaison and legal
- Medical and Technical Writing
- Labelling and Artwork
- ECTD/CTD preparation and submission to FDA (Philippines)
- Compliance check
Post-registration services
- Compliance monitoring
- Post-marketing surveillance in Philippines
- Product Recall Management
- Lifecycle Maintenace
- Line extensions
- Importer/ Distributer Assistance in Philippines
Why Partner with a Regulatory Consultant in the Philippines?
FAQs
Which is the reference drug authority in the Philippines?
How do we manage adverse drug reporting with regulatory authorities in the Philippine?
What is the fees structure for pharmaceuticals, medical devices, wellness products, animal care and veterinary products in the Philippine FDA?
What is the general timeline for regulatory approval for pharmaceuticals, medical devices, wellness products, animal care and veterinary products
What is the process for foreign manufacturers to launch their product in the Philippine market?
Our Services
Industries We Serve in the Philippines
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
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