Initiate Services: Contract Development and Manufacturing Organization

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Preliminary Formulation Data

Any prior pre-formulation/formulation data available?

Pre-formulation information

Please include a complete list of any required excipients including approved suppliers and compendial requirements. Indicate which materials Apurun must source and/or release test. In Test/Assay performed, indicate the type of data available. Examples include solubility, partition coefficient, thermal analysis, stability, polymorphism, salt characterization, impurity identification etc. If any available, please append data to this questionnaire.

Excipients/Ingredients

Test Methods and Assays Performed

Do You Prefer Apurun to Source All Raw Materials?

Desired Vendors

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Pharmacokinetic Characteristics

Desired/Required/Expected Pharmacokinetic Parameters

Describe Any Specific Organ Targeting:

Describe Any Intracellular Parameter Optimization:

Are there attachments to describe the scope requested?

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Special Considerations

Material Safety Information

Material Safety Data Sheets Attached?

Viral Safety (Biologics Only)

Has ICH viral clearance validation been completed?

Please attach Material Safety Data Sheets (MSDS) for the API. If no MSDS are available, describe material toxicity, hazards, and special handling and personnel precautions in the space below:

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We Will Response Promptly

Thank you for taking the time to complete this form. We look forward to reviewing your information and potentially moving forward to the next stages of dialogue.

Have a great day!

We Will Response Promptly

Thank you for taking the time to complete this form. We look forward to reviewing your information and potentially moving forward to the next stages of dialogue.

Have a great day!

Initiate Services: Contract Development and Manufacturing Organization

Work Scope

Specific Product Information (Optional)

API Compatibility

Preliminary Formulation Data

Pre-formulation information

API, Excipient, and Final Drug Handling Procedure (Optional)

Specify the following desired characteristics of the formulated bulk product:

Desired Final Drug Product Attributes (Optional)

Pharmacokinetic Characteristics

Analytical Methods and Validations

Method Development

Analytical Transfer

Stability Testing

Special Considerations

Material Safety Information

Viral Safety (Biologics Only)

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