How can our proven regulatory experience and expertise help your company reach its next regulatory submission milestone?
WE OFFER THE FOLLOWING SERVICES:
OUR SERVICES
CMC Regulatory Services provides submission strategy development, hands-on submission writing/editing/formatting, and dedicated project management for all types of CMC submissions. We have helped companies develop medicines across a wide range of therapeutic areas and modalities, and we are comfortable jumping in at any part of the product lifecycle. Scroll down to learn more about the specific services we offer.
Submission Production
INDs (Pre-INDs through Pivotal Trials)
BLA and NDA Module 3 (First Drafts through Final Edits)
Biologics, Small Molecules, and Combination Product Submissions
De Novo Submission Authoring or Co-writing with SMEs
Full Editing Services for All Stages of the Submission Review Cycle, from Major Overhauls to Submission Finalization
EMA & UK submissions, including CTAs, MAAs, & IMPDs
Comparability Reports and Pharmaceutical Development Reports
eCTD Formatting
Technical Report Writing that Makes Data Extraction to Module 3 Easy and Reliable
PDUFA Meeting Briefing Books, Prior-Approval and CBE Supplements, and Annual Reports
Global CMC Dossiers
Project Management
Task and Resource Management for CMC Regulatory Submissions to Achieve Timelines and Milestones
Cross-functional Module 3 Team Management
Gantt Chart Generation and Tracking
Draft Review Lifecycle Management
Veeva Workflow Management
Representation of CMC / Regulatory Affairs at Cross-functional Meetings
CMC PDUFA Meeting Planning and Coordination
Liaison with Senior Management and C-Level Leadership
Document Centralization and Organization
Interim CMC Regulatory Management
Regulatory Strategy
Strategies that Streamline Submission Approval
Control Strategy Optimization
Tailored Strategies to Navigate FDA Expedited Programs
Comprehensive FDA Communications Strategies, Including Responses to CRLs and FDA Requests for Information (RFI)
Proven Risk Management: Accurate Risk Assessment & Proven Solutions to Reduce Risk
Strategic Messaging across Regulatory Submissions
Phase-appropriate Gap Analyses
CMC Quality Target Product Profile (QTPP)
CQA / CPP Identifications & Assessments
Strategies for Successful FDA CMC Meetings
Due Diligence Readiness for Filing CMC Submission
Submission Rescue Strategies
