Translating your pipeline
through fit CMC development.
Chemistry, Manufacturing, and Controls (CMC) technical execution, rescue and expertise for small & large molecules.
Drug Substance & Product Operations
Bridging lab-scale prep into scalable, high-yield manufacturing environments.
- Active Pharmaceutical Ingredient (API) optimization
- Formulation development & stability profiling
- Analytical method development and validation scripts
Regulatory Submissions
Drafting and critical technical review of high-stakes documentation to secure clean tracks through regulatory filters.
- Comprehensive Module 3 technical authorship
- IND, NDA, and MAA strategy and assembly
- Response planning for regulatory technical inquiries
Supply Chain & Third-Party Operations
Structuring, vetting, and managing external execution networks to eliminate manufacturing and distribution risk loops.
- CDMO selection, contract structuring, and operational oversight
- Tech transfer planning and physical execution mapping
- Downstream 3PL logistics and commercial launch scale-up
Strategic Technical Diligence
Evaluating technical asset health, identifying underlying pipeline friction, and securing development assets.
- Venture capital and asset portfolio technical vetting
- SBIR and deep scientific grant technical drafting
- Sterilization approach trade-off and cost analyses
Resolving Cell Line Tech Transfer Bottlenecks
An early-stage biotech firm experienced critical yield drift and analytical method inconsistencies during a rapid biological drug substance tech transfer to a regional CDMO.
Embedded directly into the tech transfer workflow. Re-engineered analytical verification scripts, audited the CDMO bioreactor set-points, and established a clean structural cross-referencing matrix for raw stability data.
Recovered optimal product yield baseline, trimmed 4 months off the projected submission trajectory, and compiled a bulletproof Module 3 package for a successful IND path.
De-risking a Multi-Vendor 3PL & Manufacturing Architecture
A pharmaceutical client needed to uncouple their API synthesis from their final drug product tableting lines while simultaneously constructing a clean 3PL commercial shipping and storage pipeline.
Constructed a unified multi-vendor manufacturing ledger. Spearheaded terminal sterilization validation protocols to permanently bypass high aseptic processing expenditures, and mapped end-to-end 3PL hand-offs.
Designed a completely transparent supply chain blueprint that protected commercial operating margins and completed manufacturing data packages with zero critical quality observations.
Chris Sears
Principal ConsultantChris has 25-years of experience bridging the rocky terrain from drug discovery through phase-appropriate development and all the way to robust commercial manufacturing operations.
Accomplished across both small-molecule pharmaceutical and large-molecule biotech programs with a direct, execution-focused operational style. Chris builds company systems, CDMO supply chains, and submission packages that startups need to successfully navigate CMC drug development.