FROMstrategyTOsubmission
CMC Solutions:
Strategy & Submissions
From Module 3 authorship and gap resolution to clinical hold and Complete Response remediation, ELIQUENT’s team of former regulators and industry leaders provides the strategic and technical expertise needed to achieve regulatory success.
Biotech companies face intense pressure to move quickly from promising clinical data to regulatory submission. Compressed timelines, lean teams, and evolving requirements often leave organizations without the internal expertise to build a complete, submission-ready CMC package. The result: increased risk of delays, deficiencies, or setbacks that can stall development, jeopardize approval and erode investor confidence.
INFO SHEET: CMC Strategy & Submissions
CAPABILITIES SLIDES: CMC Solutions
Expert Support for Stronger Submissions
ELIQUENT delivers end-to-end support for CMC regulatory submissions, helping clients navigate complexity and reduce risk. With deep experience across modalities and regions, we align regulatory roadmaps with development milestones, strengthen filing packages, and accelerate timelines — ensuring clients can move forward with confidence.
Strategic & Technical Capabilities
ELIQUENT’s expert team and integrated capabilities ensure every filing package is complete, compliant, and strategically positioned for global success. Our areas of CMC Strategy & Submission expertise include:
Analytical Comparability
Programs to evaluate and justify manufacturing process changes
Viral Clearance Studies
Detailed risk assessments supporting regulatory submissions
Process Validation
Robust design and lifecycle strategy for consistent product performance
Shipping Validation
Comprehensive protocols to ensure integrity across distribution pathways
Biosimilar Development
Comprehensive support, including in-depth analytical similarity assessments
Compatibility & Stability Studies
In-use studies supporting clinical and commercial applications
Reference Standards
Qualification, lifecycle management, and control strategy alignment
Microbial & Aseptic Control
Microbial control, aseptic assurance, and environmental monitoring strategy development
Stability Studies
Long-term and accelerated stability studies supporting comparability and shelf-life claims
Technology Transfer
Strategic technology transfer planning, documentation, and change management governance
Analytical method
Development, qualification, validation, and transfer for release and characterization
Unmatched Expertise
ELIQUENT’s cross-functional team of former regulators, industry leaders, and technical experts brings deep knowledge across regulatory, quality, and engineering. Our CMC Solutions support life science innovators from early-phase planning through post-approval lifecycle management — tailored to fit your team, your modality, and your goals.
From Complex to Clear
Solving CMC challenges before they slow you down
Life science innovators face immense pressure to move from promising clinical data to global regulatory submission — often with limited internal resources and little margin for error. ELIQUENT’s CMC Solutions are built to solve for these high-stakes challenges, providing expert-driven, end-to-end support that accelerates timelines, reduces risk, and ensures consistent delivery across every phase of development.
Explore how ELIQUENT partners with companies to solve the most critical challenges with precision and confidence:
How targeted gap analysis, strengthened stability justifications, and Module 3 restructuring helped a biotech lift a clinical hold and keep trials on track.
Challenge.
Biotech companies advancing novel biologics may face clinical holds triggered by incomplete stability data or gaps in Module 3 documentation.
Our Solution.
These challenges can be addressed through targeted gap analysis, stronger stability justifications, and restructuring of Module 3, supported by focused preparation for agency engagement.
Outcome.
By resolving deficiencies early and aligning with regulatory expectations, companies can lift holds more quickly, resume trials on schedule, and protect investor confidence.
How region-specific Module 3 authorship, proactive gap closure, and strategic agency engagement enabled timely, compliant submissions across multiple markets.
Challenge.
Organizations moving from U.S. development into EMA, PMDA, or other global submissions often encounter compressed timelines and limited in-house expertise in regional Module 3 requirements.
Our Solution.
Success depends on region-specific Module 3 authorship, proactive gap resolution, and strategic agency engagement to clarify expectations across markets.
Outcome.
With these steps, companies achieve timely, compliant submissions worldwide, minimizing regulatory questions and accelerating progress toward approval.
How fit-for-purpose comparability frameworks, enhanced analytical methods, and focused regulatory preparation enabled confident resubmission and reduced delays for CGT developers.
Challenge.
Developers of cell and gene therapies frequently face regulatory obstacles related to comparability and potency data.
Our Solution.
The path forward requires fit-for-purpose comparability frameworks, enhanced analytical methods, and thorough preparation for regulatory meetings.
Outcome.
By addressing regulatory concerns effectively, sponsors can submit with confidence, reduce delays, and maintain momentum toward approval.
The ELIQUENT Advantage
ELIQUENT’s CMC Solutions support life science innovators from early-phase planning through post-approval lifecycle management — tailored to fit your team, your modality, and your goals.
Our unique blend of regulatory insight, technical expertise, and cross-functional delivery helps life sciences companies overcome barriers, accelerate timelines, and execute with precision. ELIQUENT’s CMC Solutions are driven by:
Deep Bench Strength
Our team includes former agency experts, seasoned industry leaders and technical engineers who understand regulatory expectations from the inside out.
Cross-Functional Delivery Model
We integrate regulatory, quality, and engineering functions —ensuring technical consistency and executive-level oversight throughout the program.
Novel Product Specialization
From CGT to radiopharmaceuticals and RNA-based therapies, we bring the nuanced understanding required for today’s most complex modalities.
Global Perspective
We help clients navigate evolving requirements across the U.S., EU, and emerging markets, ensuring submission readiness and lifecycle flexibility.
