PHARMA REGULATORY SERVICES
Pharma Regulatory Services
We take pride in quality and secure work. Our pharma regulatory services not only ensure that you comply with local laws, Philippine Food and Drug Administration regulations and industry practices; it also maintains strict confidentiality. We take pride in assisting businesses which aim to provide safe and effective healthcare products to consumers in the Philippines.
Our Pharma Regulatory Services include processing on the following documents:
License to Operate (LTO)
- LTO as Drug, Cosmetics, Household Hazardous Substances, Food, Medical Device Importer and Distributor
- LTO as Drug Re-packer with Certificate of Good Manufacturing Practice (CGMP)
- Medical Supplies
- Medical devices
- Cosmetics and household hazardous products
Before registration, we meet with you to discuss your needs, put together and review product dossiers and furnish regulatory submission process. In case you are aiming to market your product within the Philippines, we will work with you and create a marketing strategy for your product (portfolio).
The FDA is also accountable for the approval and monitoring of clinical trials within the Philippines. Companies wishing to introduce new and progressive products have to first register with FDA, after which they are going to be granted a temporary CPR to use for the medical trial, which then requires standard reporting.
Eternus Global Pharma Regulatory Services
Eternus Global Company KPO can assist your organization in processing and obtaining LTOs and CPRs from FDA, while also offering services for pharmaceutical traders and entrepreneurs who want to do business within the Philippines.