Critical Information Request – Due Diligence, CTD Gap Analysis & Serialization Readiness
To prepare a comprehensive evaluation for the transfer of your manufacturing and packaging to a UK or EU site, please complete the following questionnaire. Where detailed answers may also be found in the CTD, please provide a summary below.
The CTD should be uploaded to the link provided separately via e-mail. To may request a new link from: BD@oakleyBD.com
Contact Information
1. Regulatory Submissions & Dossiers
2. Current Manufacturing & Quality Systems
3. Technology Transfer Requirements
4. Packaging & Serialization
5. Commercial Objectives
6. Risks & Constraints
7. Documentation Provided
Only the FDA dossier (CTD) is required at this time.
Other documents can be uploaded at your discretion based on relevance
The completed questionnaire will be saved and stored securely. Please upload the CTD and optional supporting documents using the link sent to you separately
via e-mail. (To request a new link: BD@OakleyBD.com)
Data Protection Notice:
Oakley Business Development Limited is committed to protecting your personal and company data in accordance with the UK General Data Protection Regulation (GDPR) and the Data Protection Act 2018. The information provided in this questionnaire will be used solely for the purpose of conducting business due diligence, regulatory gap analysis, and technology transfer evaluation activities.Data will be stored securely, retained only as long as necessary for the stated purpose, and will not be shared with third parties without your explicit consent.
You have the right to access, amend, or request deletion of your data at any time by contacting BD@OakleyBD.com.
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