Contact information

Name and Title:

Company Name:

Street Address:

City: State: Zip Code:

Country:

Telephone: Fax: e-mail:

Today's Date: Desired Time Frame:

What services do you expect to need (check all that apply)?

Product Name:

Dosage Form: Strength/Concentration:

Quantity Needed:

Final Container Size and Fill Volume or Count:

A. Is the drug substance or active component used in your drug product a penicillin, cephalosporin, monolactam compound or its derivative, or a biologic (e.g., live/attenuated virus)? Yes No

B. What is the chemical name of the drug substance?

C. Has your active ingredient been properly evaluated by an environmental health and safety department or company for assessment concerning occupational exposure limits (OELs), occupational hazard category (OHC), and do you have handling guidelines for it? 
Yes (This documentation, including an MSDS, will need to be provided before a  final decision can be made about our ability to handle your compound in our facility.)  
No (This assessment must be completed before a final decision can be made about our ability to handle your compound in our facility.)
NA (Dosage form does not contain a drug substance or active component.)

D. What is the general chemical class of the active ingredient?

E. What is the general therapeutic class of the active ingredient?

F. Is the drug substance, active component, or any part of your drug product radioactive?
Yes (What is/are the radioactive isotopes? )

No             

G.  Is the drug substance or active component used in your drug product a controlled substance according to the Drug Enforcement Agency (DEA)?                

Yes (Please indicate its Schedule (I, II, III, IV, or V) )

No

H. Is your product intended for Clinical Trials or Commercial Sale?

Clinical Trials
Commercial Sale
Other

I. At what stage of the development process are you?

Preclinical

Phase I

Phase II

Phase III

Post NDA/ANDA/BLA

Not Applicable

J. What country or countries will your drug product be used in?