Primary Contact

Name

Company

Address

City/State/Zip

Phone

Email

Website

Secondary Contact

Name

Phone

Email

Product Indication

Product Name

Chemical Name

Dosage Form:

Liquid Lyophilized Suspension Other

Pre-Clinical Phase I Phase II Phase III Commercial

Development Batches

(# of lots)

Lot size (#of Vials)

Desired Delivery

Commercial Batches

(# of lots)

Lot size (#of Vials)

Desired Delivery

Estimated date of commercialization:

Estimated commercial sales (in individual units/vials):

Year 1

Year 2

Year 3

Is a Material Safety Data Sheet (MSDS) available?

Yes No (If Yes, PLEASE EMAIL TO kristin.calloway@osobio.com)

Has safety evaluation been performed?

Yes No (If Yes, PLEASE EMAIL TO kristin.calloway@osobio.com)

Active Ingredient concentration

Fill Volume

Non-compendial ingredients:

Yes No

Non-compendial ingredients

Co-Solvent?

Yes No

Product or contact Incompatibilities:

Yes No

If Yes, Please Describe

Does this process require any specialized equipment?

Yes No

If Yes, Please Describe

Are there any handling or special processing requirements?

Yes No

Foaming

Yes No

Oxygen sensitive

Yes No

Viscous

Yes No

Shear

Yes No

Light sensitive

Yes No

Other Special Handling Requirements

Sterile filtration of final product:

Yes No

Aseptic processing:

Yes No

If product is sterile filtered, has filter validation been performed?

Yes No

Are product cleaning procedures available?

Yes No (If Yes, PLEASE EMAIL TO kristin.calloway@osobio.com)

API Storage:

Ambient Refrigerated (2-8C) Frozen (-20C) Other

Ambient Compounding/Filling:

Ambient Refrigerated (2-8C) Frozen (-20C) Other

Final Product Storage:

Ambient Refrigerated (2-8C) Frozen (-20C) Other

Is Terminal Sterilization required for the product?

Yes No

Terminal Sterilization Method

Steam Other

Is Product Lyophilized?

Yes No

Total Lyophilization time (hours):

Active Ingredient Incoming Testing

FTIR UV HPLC

Other (please list):

Inactive Ingredient Testing (Please list below)

In Process Testing (Please list below) Note: Pre-filtration Bioburden is required

Final Product Testing (Please list below) Note: USP Sterility, Endotoxin & Partculates required

Will OsoBio be performing stability studies?

Yes No (If Yes, PLEASE EMAIL TO kristin.calloway@osobio.com)

Special visual inspection characteristics?

Yes No

If yes, describe:

Ink jet required

Yes No

If yes, note location;

Seal Vial Secondary Packaging

Labeling Required?

Yes No

Note: OsoBio strongly recommends that all finished product vials be labeled or ink-jetted with the lot number.

Packaging Required (If applicable)?

Yes No

Shipping Validation Required?

Yes No

If yes, to be provided by:

Customer OsoBio (outsourced)

Are you willing to use a site-qualified container closure system (vial, stopper, seal)?

Yes No If no, please enter current product component description below.

Vial:

Manufacturer:

Description or part #

Tubing Molded Amber
Clear Treated Untreated

Size (mL):

Finish (mm):

Stopper:

Manufacturer:

Description or part #

Coating:

Teflon Fluorotec B2 Other

Aluminum seal:

Manufacturer:

Description or part #

Color: