CMC Regulatory Services, LLC
CMC Regulatory Services, LLC is an agile biopharmaceutical consultancy specializing in effective submission strategies and their execution for the efficient production of successful regulatory submissions. We focus on the strategy, writing, and project management of CMC regulatory submissions, from Pre-INDs to INDs, BLAs, NDAs, post-approval supplements, and more.
Companies of all sizes have relied on CMC Regulatory Services to help bring vital, life-saving therapies and drugs to the patients who need them by providing innovative and efficient solutions to complex regulatory challenges. Our expertise spans biologics, small molecules, and combination products supported by deep experience in CMC regulatory affairs across all required submission activities.
We can provide the comprehensive support needed to produce a complete Module 3 on an aggressive timeline. Our team is agile enough to start contracts quickly, hit the ground running, and get the job done on schedule. We are experts at integrating the necessary and critical information about your product that FDA requires and expects in CMC submissions. Our objective is to combine client expertise with our applied Module 3 experience to produce a bulletproof submission.
Our services include regulatory strategy development, hands-on submission writing/editing/formatting, and dedicated project management for all types of CMC submissions and related documentation, including:
Pre-INDs
INDs
NDAs
IMPDs
DMFs
BLAs
Pre-Meeting Dossiers & FDA / HA Communication
Responses to FDA Complete Response Letters (CRLs) and Requests for Information
Post-Approval Supplements
cGMP Documentation
We also serve as FDA liaison and provide interim CMC regulatory leadership.
For a comprehensive overview of the services we provide, click the buttons below:
We Thrive on Challenges:
Performing detailed gap analyses for products developed/approved in foreign countries that sponsors want to bring to the US
Figuring out how to best present complex manufacturing changes for a cutting-edge new class of therapeutic
Rescuing INDs, NDAs, and BLAs after an unfavorable FDA response
Making optimal use of all available data to satisfy FDA expectations while avoiding costly delays associated with unanticipated testing
Contact us today!
