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IQ Sciences can consult, prepare, and submit your FDA DMF Type III Packaging Materials and Components information.

The DMF system was established as a route for manufacturers of drug and biologic substances or packaging components to submit confidential or proprietary information to the Food and Drug Administration (FDA) that may then be referenced in support of a regulatory application. IQ Sciences is committed to uphold the confidentiality of all information we receive, research and process for our clients.

The responsibility for providing information about packaging components rests foremost with the organization submitting the regulatory document to the FDA in order to obtain FDA approval of a new drug or biological product.  This information may be provided by the manufacturer of a packaging component or materials of construction to the applicant who may include it directly in the application. 

A Type III DMF becomes necessary when there is information that a packaging component manufacturer does not wish to share with the applicant because it is considered confidential. The Federal Drug Administration has specific extensive requirements as to what information is necessary for a Type III DMF.

IQ Sciences works with you the manufacturer and DMF Holder to ensure your DMF has no deficiencies.

IQ Sciences will research and prepare the following:

Administrative Information

Letters of Authorization

Product Description Information

Product Manufacturing Processes

Product Specifications

Product Test Methods

Product Quality Systems

At IQ Sciences, we pride ourselves on Quality Service, close effective communication, and developing a long lasting relationship with our clients.

As a small business, IQ Sciences works with you to meet your goals at an affordable price that is mutually reasonable and within your budget.

Please contact us for more information.

Agent

Alternate Materials

Alternate Suppliers

Applicant

Biologics License Agreement

Certificate of Analysis

Certificate of Compliance

cGMP

Code Federal Regulations

Compatibility

Container closure system

DMF Holder

Drug product

Extractable

Interchangeable Materials

Investigational New Drug

Letter of Authorization

Low Density Polyethylene

Materials of construction

Packaging component

New Drug Application

PFA

Packaging Material Name

Packaging system

Performance Criteria

Polyethylene Terephthalate

Polypropylene

Polyvinyl Chloride

Primary packaging component

Protection

Quality Assurance

Quality Control

Raw Materials

Release Controls

Resins

Safety

Secondary packaging component

Sponsor

Stabilty Studies      

Sub-assembly component

Supply Chain

U.S. Pharmacopeia