What We Do

Services Built for Where You Are

Every engagement is scoped to your program's current stage — not a template lifted from a larger company. We bring the experience to know what matters now, and the discipline to leave the rest for later.

01 CMC Strategy Development 02 Regulatory Support 03 Supply Chain Mapping 04 Clinical Supply Operations
01
Core Service

CMC Strategy
Development

We craft stage-appropriate CMC plans that align with your clinical objectives and regulatory milestones. From IND-enabling studies through Phase III, we define what matters now — and what can wait — so your team moves efficiently without unnecessary risk.

IND Strategy Phase I/II/III Tech Transfer CMC Readiness
What We Cover
  • Development of an integrated CMC roadmap aligned to your IND, Phase I, II, and III milestones
  • Stage-gated prioritization of CMC activities — analytical development, formulation, process development, and stability
  • Technology transfer planning and oversight across internal and external sites
  • CMC gap assessments to identify risks before they delay your program
  • Cross-functional alignment across Technical Operations, Quality, and Regulatory
Typical Deliverables
CMC RoadmapStage-gated plan tied to clinical milestones
Gap AssessmentRisk-ranked CMC readiness review
Tech Transfer PlanSite and process transfer strategy
CMC GovernanceDecision framework and escalation path
Who This Is For
  • Early-stage biotechs preparing their first IND or moving into Phase I
  • Companies transitioning from academic or discovery-stage CMC to GMP-ready programs
  • Teams that need an experienced CMC lead without a full-time hire
02
Core Service

Regulatory
Support

Regulatory success starts with documentation that is complete, coherent, and calibrated to your stage. We translate your program's data into clear, submission-ready packages that tell a compelling story to agencies.

CMC Authoring CTD / eCTD IND / IMPD Regulatory Writing Submission-Ready CMC Package
What We Cover
  • Authoring and structuring the CMC modules of your CTD dossier for IND, IMPD, NDA, and BLA submissions
  • Drug substance and drug product sections written to agency expectations
  • Analytical methods, specifications, stability data, and container-closure documentation
  • Post-approval CMC change documentation and supplement strategy
  • Preparation for pre-IND and Type B meetings with FDA or EMA on CMC topics
Typical Deliverables
CMC ModulesAuthored CTD sections, reviewer-ready
Submission PackageComplete, eCTD-formatted CMC dossier
Agency Meeting PrepBriefing documents and Q&A preparation
Change SupplementsPost-approval CMC change strategy
Who This Is For
  • Companies preparing their first IND or IMPD submission
  • Teams without dedicated CMC regulatory writing resources
  • Programs approaching NDA or BLA needing CMC module support
03
Core Service

Supply Chain
Mapping

We build a clear, comprehensive picture of your supply chain — CDMOs, raw material suppliers, testing labs, and logistics partners. Understanding dependencies and risks before they become problems is the foundation of a reliable clinical supply program.

CDMO Selection Vendor Mapping Risk Assessment Dual Sourcing
What We Cover
  • End-to-end supply chain mapping across drug substance, drug product, testing, and distribution
  • CDMO landscape assessment and selection support for biologics, ADCs, and complex modalities
  • Vendor qualification strategy and governance framework
  • Single-source risk identification and dual-sourcing strategy where critical
  • Raw material risk assessment including critical excipients and single-source components
Typical Deliverables
Supply Chain MapVisual end-to-end supply network
CDMO ShortlistRanked candidates with fit assessment
Risk RegisterPrioritized supply chain risk inventory
Sourcing StrategySingle vs. dual sourcing recommendations
Who This Is For
  • Companies building their external manufacturing network for the first time
  • Programs moving from a single academic or research-grade supplier to a GMP supply chain
  • Teams that have grown their supply chain organically and need a structured risk review
04
Core Service

Clinical Supply
Operations

We establish reliable, streamlined processes to support your clinical milestones. From demand forecasting and material release workflows to batch records and deviation management — we implement the right level of rigor without bureaucratic burden.

Demand Planning GMP Oversight Batch Release Inventory Mgmt
What We Cover
  • Clinical demand forecasting and supply planning aligned to trial timelines and enrollment projections
  • Material release processes, batch record review, and certificate of analysis management
  • Inventory management strategy — safety stock, resupply triggers, and expiry management
  • Deviation and CAPA oversight to maintain GMP compliance without over-engineering
  • Clinical supply SOPs sized for lean biotech teams
Typical Deliverables
Supply PlanDemand-driven clinical supply forecast
Release WorkflowBatch release and QC process design
SOP PackageRight-sized GMP-compliant procedures
Inventory ModelStock strategy with reorder logic
Who This Is For
  • Companies entering their first clinical trial and establishing supply operations
  • Teams whose processes have not kept pace with their growing program complexity
  • Organizations preparing for regulatory inspection of their clinical supply practices
Ready to Get Started?

Not Sure Where to Begin?

Most programs need a combination of these services. Start with a conversation — we'll help you figure out what your program needs most right now.

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