Main Contact

Name

*

Title

*

Company Name

*

Address

*

TEL

* (example: 555-555-5555)

F AX

* (example: 555-555-5555)

Email Address

* (example: bob@msn.com)

Status of the product

Change of site IND Feasibility Study Toxicity Study Pre-clinical

Phase I Phase II Phase III

ANDA NDA Other:

Cytotoxic ?

Yes , No

Containment level: Do not know the levels

Timeframe

Estimated start date:

Estimated completion date:

Temperature Range

Ambient

Specific Range:

Any humidity constraints?

Yes , %RH

No

Any special shipping & handling instructions Please describe:

Packaging Configuration
Specifications (i.e., glass bottle, metal cap, etc.):

Batch Size (in number of units or in kg)

Demo :

Clinical:

Commercial:

Formulation ready?

Yes No

Analytical method available?

Yes No

Validated ? Yes No

Stability required?

Yes No

Conditions:

Time Points:

Process required

Granulation Coating Other:

Special formulation technique required?

ODT Modified Release Other: