Regulatory Services

Offers Product Registration Assistance and Technical Documents Preparation

We offer Registration Services for Pharmaceuticals and Non-Pharmaceuticals

We Conduct Technical Assistance to comply with the:

* ACTD ( ASEAN Common Technical Dossier )
* ACTR ( ASEAN Common Technical Requirements )

Such as:

• Stability Data/Storage
• Analytical Method Validation
• Process Validation
• Dissolution Profiles

FDA licenses have been issued to SPRLI to operate as:

• Drug Manufacturer (includes Veterinary Products)
• Cosmetic Laboratory
• Food (Health Supplements) Manufacturer and Distributor (Importer)
• Household Hazardous Substances Manufacturer
• Medical Devices Manufacturer

Certificate of Accreditation from the Bureau of Health Facilities and Services of the Department of Health (DOH) as:

• Water Testing Laboratory

BFAD certificate of Good Manufacturing Practice (CGMP) has been issued to SPRLI

Regulatory Services

• Product registration application with the FDA
• Monitoring of release of CPR from the FDA
• Compilation of pertinent documents required for each product by the FDA
• Such other services necessary for the completion of regulatory compliance in accordance with the ASEAN Harmonized Guidelines of the Pharmaceutical Industry