Analytical Testing Inquiry | Globyz Clinical Solutions

1

Personal / Contact Information

First Name *

Last Name *

Company / Organization *

Job Title

Business Email *

Telephone Number

Country *

Company Website

2

Type of Request

How can Globyz Clinical assist overall? *

Request a laboratory quotation Method development & validation Analytical testing / release testing Dissolution / Release rate testing Stability testing / Storage Extractables & Leachables study / guidance Comparative dissolution testing Professional / Strategic partnership Other

3

Confidentiality Requirement

Confidentiality agreement is already executed between the parties Please send a standard NDA template to the email provided NDA / CDA is required before detailed discussion (a standard NDA template can be provided) Preliminary discussion only (no confidential details will be shared initially)

4

Product Information

Can the product or program name be disclosed at this stage? *

Yes No (please use code name or study program)

Product Name or Code / Description *

Product Category *

Formulation / Sample Type *

General Indication / Description

Developmental Stage

5

Testing Required

Select all applicable analytical services: *

Assay Dissolution / Release Impurities / Related substances Forced degradation Residual solvents Method development Elemental impurities (ICP-MS) Method validation & transfer Heavy metals Accelerated stability testing pH / Viscosity Long-term stability testing Physical testing Release testing Microbial limit testing Raw material testing Sterility testing Excipient testing Endotoxin testing Container closure integrity Water testing Special / Custom testing Other

6

Method Status

Current Method Status *

Availability of Methods and Specifications

Method Transfer Option:

Will provide compendial / client method Require Globyz to develop method Need method validation / verification Undecided / Need guidance

7

Regulatory Context

Health Canada US FDA (US-FDA) European Medicines Agency UK MHRA Japanese PMDA TGA Australia WHO / International Other

8

Preliminary Sample Information

Approximate Number of Products

Approximate Number of Batches / Lots to be tested

Approximate Number of Samples per Lot

Estimated Total Number of Samples

Required Storage Temperature / Stability

Special Handling / Safety Precautions

Current Sample Location

Have samples been shipped to Canada in past?

9

Storage and Handling

Does sample require special handling?

10

Timeline and Reporting

Preferred Turnaround Time *

Target Completion Date

Format of Reporting Required:

Certificate of Analysis (CoA) Analytical Report Full Validation Report Raw Data package Electronic Data Summary Verification Report Summary / Letter Format Custom / Client template

11

Non-Confidential Project Summary

High-level description of proposed testing and supporting details:

12

Preferred Meeting Slot

Preferred Contact Method

Preferred Date

Preferred Time

Time Zone

13

Confirmation and Consent

I confirm that the information provided in this inquiry is accurate to the best of my knowledge * I understand that submitting this inquiry does not create a binding commercial contract but initiates preliminary technical evaluation * I consent to Globyz Clinical contacting me regarding this inquiry and storing submitted information for communication purposes * I would like to receive periodic updates on Globyz Clinical services and industry insights

Need Analytical Testing
in Canada?

Confidentiality and Preliminary Notice

Personal / Contact Information

Type of Request

Confidentiality Requirement

Product Information

Testing Required

Method Status

Regulatory Context

Preliminary Sample Information

Storage and Handling

Timeline and Reporting

Non-Confidential Project Summary

Preferred Meeting Slot

Confirmation and Consent

Need Analytical Testing in Canada?

Confidentiality and Preliminary Notice

Personal / Contact Information

Type of Request

Confidentiality Requirement

Product Information

Testing Required

Method Status

Regulatory Context

Preliminary Sample Information

Storage and Handling

Timeline and Reporting

Non-Confidential Project Summary

Preferred Meeting Slot

Confirmation and Consent

Need Analytical Testing
in Canada?