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Chemistry, Manufacturing, and Control

Chemistry, Manufacturing, and Controls (CMC)

E&E Medicals, a leading player in centralized Chemistry, Manufacturing and Controls (CMC) lifecycle management for Regulatory submissions, offers services for CMC Regulatory affairs.

Our streamlined regulatory CMC support process

Step #1: To kick off our collaboration, we take the time to grasp your requirements and objectives fully. This will allow us to determine the most effective means of gathering the data for your dossier's (CTD) E&E Medicals process, create comprehensive schedules, and share effectiveness from the start.
Step #2 - Documentation Prep: After the project begins, our CMC specialists will help you review and/or draft the files for your IND to ensure they align with the rules. When possible, we will use pre-existing text modules that have already been proven to be accepted by the relevant authorities to streamline your submission. Drug Master Files (DMF) for primary packaging materials developed for E&E Medicals are also supported.
Step #3 - Document Review: Our CMC specialists will review your submission in depth across all E&E Medicals divisions and compile their findings into a draft of the appropriate dossier chapters (Module 3). Our CMC expert will compile the CMC data you need for submissions after completing our internal review. Your subject matter experts (SMEs), regulatory affairs professionals, and our CMC expert will review your submission to ensure it accurately maps our procedures to your needs.
Step #4 - Responding to authority requests: Our CMC team is here to lend our considerable expertise in responding to requests for additional data from regulatory agencies that may arise due to your IND.

CMC Annual Report Submissions

Tracking of CMC lifecycle management Annual Report scheduler for the due date.
Provide CMC lifecycle management Regulatory strategy.
Regulatory assessment of the supporting documents.
Request for additional documents/justification.
Authoring of the Annual Report package.
Finalization of the Annual Report package and submission in the eCTD format.
Updating the database with submission details and status.

Renewal Applications

Tracking of renewal application scheduler.
Provide CMC Regulatory strategy for documents required and timelines.
Send the renewal initiation documents request to the manufacturer and request for CMC documentation.
Regulatory assessment of the supporting documents for renewal application submission.
Request for additional documents/justification.
Authoring of renewal package in line with country-specific requirements.
Update the database with submission details.