Processing International and Domestic CPRs.

Once Manufacturer or new source is identified or we start discussions we have to enter in to an Agreement which is signed by both parties and should be legalized at Philippine Embassy from Sourcing Country and then this Agreement along with WHO-GMP certificate of the Mfg. Site we submit at FDA Philippines to add Manufacturer in our List of Sources ( on our Business License to Operate ,i.e. LTO)

We have dedicated Regulatory Department which handles Registration of Drugs , Cosmetics, Devices ,Food Supplements etc. and they liaises with Manufacturer and FDA Philippines on regular basis for Initial Submissions of Dossiers, Renewals , Compliances , and other requests.

Our Requirements is Dossiers in ACTD or even National Guidelines format along with COPP ( Certificate of Pharmaceutical product issued/verified by FDA of the Sourcing Country ) and Samples . All these should be consistent and complete in all respects for us to submit at FDA Philippines.

Registration time takes about 10-12 months for Drugs, Biologicals and lesser for Cosmetics ,Devices ,Food supplements, Herbals ,Household etc.

Securing of Certificate of Product Registration with FDA for Food or Drug, or Chemical Products
Securing of License to Operate (LTO) on Drugstores, Distributors, & Importers

Assistance with Clinical Research:

• Bio-equivalence & Bio-availability
• Pre-clinical studies
• Clinical trials (Phase I-IV)
• Safety and Efficacy Studies
• Health Evaluation Studies
• Laboratory Analysis
• Biostatistics
• Medical writing and publication