Obstacles in Complex CMC Submissions

Compressed development timelines with under-resourced regulatory teams

The Challenge.
Biotech companies face intense pressure to rapidly transition from promising clinical data to regulatory submission — but many lack the internal expertise needed to build a complete, submission-ready CMC package.

Our Solution.
ELIQUENT delivers end-to-end support for CMC regulatory submissions, including full-service Module 3 authorship, strategic gap analysis, and proactive remediation of clinical holds or agency comments. Our experts define regulatory roadmaps aligned with development milestones, guide preparation for agency interactions, and support efficient responses to feedback. With deep experience across modalities and regions, we help clients reduce submission risk, accelerate timelines, and move forward with confidence.

We Deliver.
Fewer delays, stronger filings, faster path to market.

Regulatory Uncertainty in Advanced Modalities

Modality complexity demands specialized insight

The Challenge.
Developers of cell and gene therapies, RNA-based platforms, and biologics face complex, modality-specific challenges in analytics, comparability, and regulatory strategy. Limited internal expertise often leads to missteps in control strategy, global submissions, and engagement with regulators — resulting in development inefficiencies, delays, and regulatory pushback.

Our Solution.
We bring deep, hands-on expertise in advanced modalities — spanning CGT, RNA, and biologics — to guide your regulatory strategy, control strategy, and comparability planning. Our team understands the nuance of global submissions for complex products and helps define the right regulatory path for your therapy, ensuring confident execution at every stage.

We Deliver.
Smarter decisions, higher regulatory confidence, and reduced development risk.

CDMO Inefficiencies & Tech Transfer Roadblocks

Overdependence on CDMOs and missteps in technical oversight can derail scale-up

The Challenge.
Tech transfer to CDMOs is a high-risk, high-stakes process — especially for small and mid-sized biotechs that depend heavily on external partners. Without strong alignment, thorough planning, and on-site technical oversight, transfers often break down — leading to missed timelines, quality issues, and delays in scale-up or submission readiness.

Our Solution.
ELIQUENT’s team of experts provide readiness assessments, develop transfer protocols, and provide on-site technical oversight of CDMO activities. Our governance-driven approach includes real-time performance monitoring and proactive troubleshooting — ensuring accountability, minimizing delays, and enabling smooth, on-time tech transfers and efficient scale-up.

We Deliver.
Smoother tech transfers, fewer late-stage surprises, and faster scale-up.

Underdeveloped Quality & Compliance Functions

QMS gaps can stall progress and lead to increased risk

The Challenge.
Emerging biotechs often lack the deep quality expertise needed to build a compliant QMS and prepare for inspection. Without robust systems and proactive planning, companies risk 483s, warning letters, costly remediation, and delays — especially when speed has been prioritized over infrastructure.

Our Solution.
ELIQUENT quality experts — many of them former FDA and EMA inspectors — provide inspection readiness assessments, mock audits, and QMS strategy implementation.

We help build compliant quality systems from the start, close gaps early, and support remediation of known issues to avoid repeat findings and regulatory delays.

We Deliver.
Inspection readiness, improved compliance posture, and peace of mind.

Fragmented CMC Governance Structure

Lack of structure across teams and disconnected efforts leads to missed milestones

The Challenge.
CMC programs span multiple functions, partners, and geographies — making coordination complex and resource-intensive. Many biotechs lack the internal bandwidth or structured oversight to effectively manage activities across IND, tech transfer, and global submissions. Without integrated governance, teams risk poor alignment, missed milestones, and costly delays.

Our Solution.
We provide integrated CMC program governance that includes portfolio oversight, phase-based planning, and technical project management. Through tools like real-time dashboards and scenario planning, we align stakeholders, track cross-functional dependencies, and keep complex programs on schedule — from IND through global submissions. 

We Deliver.
Increased visibility, fewer missed handoffs, and a more efficient path to submission.