Food and Drug Administration (FDA)

Covered Services:

• Compilation of documents
• Submission to FDA
• Payment process of FDA fees
• Follow-up Status
• Receiving of approval/results from FDA

1.1 Initial — Importer / Wholesaler / Distributor

Timeline Max: 2-3 months

FDA Requirements:

• Permit/Brgy. Clearance
• SEC/DTI
• ID of Authorized Person

1.2 Renewal — Importer / Wholesaler / Distributor

Timeline Max: 2-3 months

FDA Requirements:

• A copy of Existing LTO

1.3 Amendment / Notification / Variation

Timeline Max: 2-3 months

FDA Requirements:

• Copy of Existing LTO

*For further discussion, requirements depend on the Notification type to be apply

Covered Services:

• Documents Evaluation & Compilation
• Managed/Correct the documents as per FDA guidelines
• Submission to FDA
• Payment process of FDA fees
• Follow-up Status
• Receiving of approval/results from FDA

2.1 Initial — Low Risk, Medium Risk, High Risk, Raw Materials

Timeline Max: 3-4 months

FDA Requirements:

• LTO of Importer
• WHO GMP / ISO / FSC / Purchase Order
• FG COA
• Artwork/Lay-out
• Product Image
• Eportal Account Username and Password

2.2 Renewal — Low Risk, Medium Risk, High Risk, Raw Materials

Timeline: 2 months

FDA Requirements:

• LTO of Importer
• WHO GMP / ISO / FSC / Purchase Order
• FG COA
• Artwork/Lay-out
• Product Image
• Eportal Account Username and Password

2.3 Amendment / Notifcation / Variation

Timeline: 1 month

FDA Requirements:

*For further discussion, requirements depend on the Notification type to be apply.

*per type of amendment

Covered Services:

• Documents Evaluation & Compilation
• Managed/Correct the documents as per FDA guidelines
• Submission to FDA
• Payment process of FDA fees
• Follow-up Status
• Receiving of approval/results from FDA

3.1 Initial — Rx

Timeline Max: 24-36 months

FDA Requirements:

*Will share the FDA requitements separately.

*Prerequisite to apply GMP application of Manuf.

3.2 Initial — OTC / HR

Timeline Max: 8-16 months

FDA Requirements:

*Will share the FDA requitements separately.

*Prerequisite to apply GMP application of Manuf.

3.3 Automatic Renewal — Rx

Timeline Max: 2-4 months

FDA Requirements:

*Will share the FDA requitements separately.

*Prerequisite to apply GMP application of Manuf.

3.4 Automatic Renewal — OTC / HR

Timeline Max: 2-4 months

FDA Requirements:

*Will share the FDA requitements separately.

*Prerequisite to apply GMP application of Manuf.

Covered Services:

• Documents Evaluation & Compilation
• Managed/Correct the documents as per FDA guidelines
• Submission to FDA
• Payment process of FDA fees
• Follow-up Status
• Receiving of approval/results from FDA

FDA Requirements:

• Letter of Request
• Apostilled and/or Legalized GMP Evidence, such as WHO GMP, EU GMP
• Annex C
  • Plant Inspection Report (Latest)
  • Manufacturer’s CAPA
  • Validation Master Plan
  • Rationale for test Method Validation, Procedure for Method Transfer, etc.
  • Procedure for Handling Deviation
  • Site Master File
  • Annex B
  • Annex E
• NOC from other Importer
• NOC from manufacturer
• Latest LTO Copy (importer)

4.1 FGMP application

Initial — PICS Manuf./as Desktop evalution only

Timeline Max: 3-6 months

4.2 FGMP application

Initial — Non-PICS Manuf./need a Plant Inspection

Timeline Max: 12-24 months

*Will occur additional if there’s plant inspection

Timeline Max: 3-4 months

Covered Services:

• Documents Evaluation & Compilation
• Managed/Correct the documents as per FDA guidelines
• Submission to FDA
• Payment process of FDA fees
• Follow-up Status
• Receiving of approval/results from FDA

FDA Requirements:

• License to Operate
• Manufacturer’s License
• Unit Dose and Formulation
• Finished Goods certificate of Analysis
• Image of the Finsihed Goods