We manufacture and sell the durable poly style IND, NDA and Drug Master Binders to over 500 pharmaceutical companies. Our binders and folders meet all requirements for IND and NDA drug submissions to the FDA.
Please download the order form below to see current pricing.
If you would like to place an order please send your completed order form to firstname.lastname@example.org or fax to (847) 224-9741.
What are Poly FDA Binder Requirements?
- FDA Binders must be high impact plastic that can withstand temperatures up to 150 degrees.
- FDA Binders should have a smooth surface that will allow printing on the surface, that will bond and dry in one hour.
- FDA Binders should be free from streaks, blisters, scratches, mottling.
- FDA Binder weight must be .023 to .025 gauge.
- FDA Binder ink color must be black.
Poly FDA Binders Include:
- FDA Form 2626 - Blue (NDA Archival Binder)
- FDA Form 2675 - Red (IND Archival Binder)
- FDA Form 3316 - Red (Drug Master File)
- FDA Form 3316a - Blue (Drug Master File Archival Binder)
What are Paper FDA Binder Requirements?
- Front (flat) size must be 267 x 292mm (10 1/2" x 11 1/2")
- Back (flat) size must be 267 x 305mm (10 1/2" x 12"). Includes 13mm (1/2) lip at top.
- FDA paper binders must be of 11-point plate rope stock that is extra heavy weight.
- Ink color must be black. Maroon binder ink color must be white.
Paper FDA Binders Include:
- FDA Form 2626a - Red (NDA Chemistry Binder)
- FDA Form 2626b - Yellow (NDA Pharmacology Binder)
- FDA Form 2626c - Orange (NDA Pharmacokinetic Binder)
- FDA Form 2626d - White (NDA Microbiology Binder)
- FDA Form 2626e - Tan (NDA Clinical Data Binder)
- FDA Form 2626f - Green (NDA Statistics Binder)
- FDA Form 2626h - Maroon (NDA Field Submission Chemistry Binder)
- FDA Form 2675a - Green (IND Chemistry Binder)
- FDA Form 2675b - Orange (IND Microbiology Binder)
For more information on FDA Binder Guidelines, visit fda.gov.