Your CMC programs, delivered on time and to standard.
Drug development is complex, high-stakes, and unforgiving of delays.
I help biotech and pharma companies move their CMC programs forward —
with the right strategy, the right regulatory approach, and AI-driven tools
that cut through complexity.
// your programs
Where we can work together
DS/DP Process Development
Moving from concept to development-ready process takes tight coordination across formulation, analytics, and manufacturing. I provide the CMC leadership to keep all workstreams aligned and progressing on schedule.
GMP Manufacturing Readiness
Getting to a first GMP campaign is one of the most complex milestones in drug development. I coordinate across QA, manufacturing, supply chain, and analytical teams to make sure everything is in place when it needs to be.
CDMO Selection & Oversight
Finding the right external manufacturing partner — and managing them effectively — is critical to program success. I support the full lifecycle from technical due diligence and selection through to technology transfer and ongoing oversight.
CMC Regulatory Strategy & Submissions
A strong CMC dossier is built long before the submission deadline. I help structure the regulatory strategy early and support preparation of IND, CTA, and MAA filings — so the technical package reflects the quality of the work behind it.
Program Leadership & Cross-functional Coordination
Complex CMC programs involve many moving parts across functions and organizations. I bring structured project leadership to align teams, manage timelines, and keep decision-making clear — at any stage of development.
AI Integration in CMC Workflows
There is real value in applying AI to CMC — but only in the right places. I help teams identify where data-driven tools and process intelligence can make a genuine difference, and support practical implementation in a regulated environment.
// the approach
Embedded expertise, not generic advice.
I work closely with your team — not at arm's length. Every engagement starts with understanding your specific program, stage, and constraints before recommending anything.
Whether it's a short-term advisory or a multi-month embedded engagement, the goal is the same: tangible progress on your CMC program.
01
Understand your program
A focused intake conversation to map your current state, priorities, and blockers — no generic intake forms.
02
Define the engagement
Together we agree on scope, timeline, and deliverables — tailored to what your program actually needs right now.
03
Deliver and iterate
Hands-on execution with regular checkpoints — strategy, documents, decisions, and team capability built in parallel.
04
Transfer and close
Every engagement ends with a clean handover — knowledge, documentation, and processes fully embedded in your team.
// the mission
Bringing the precision of modern science to the management of drug development.
// AI in CMC
Bringing AI where it actually helps.
AI in drug development isn't hype — but only when applied to the right problems. I help teams identify where AI-driven tools create real value in CMC workflows, and implement them in a way that's regulatory-compliant and practical.
Process intelligence & analytics
Turning manufacturing and analytical data into actionable decisions — faster root cause analysis, smarter process monitoring.
Regulatory document acceleration
AI-assisted drafting and review of CMC dossier sections — cutting preparation time without cutting quality.
Decision support systems
Structured frameworks and AI-enabled tools that help cross-functional teams make better CMC decisions, faster.
Luka Kotrikadze
Biopharmaceutical Program Leader · Berlin
Forbes 30 Under 30
Hands-on experience across DS/DP process development, formulation, analytical method development, GMP manufacturing readiness, and technology transfer
Broad modality coverage: mRNA, biologics, ATMPs, small molecules, gene therapy, bacteriophage-based products, and orphan drugs
Based in Berlin — available across Europe
// about
The expertise behind the work.
In my career, I have been part of some of the most demanding drug development programs of the last decade — where delays cost lives and regulatory mistakes cost years. That experience shapes how I approach every engagement: with rigour, speed, and an eye on what actually matters.
Today I work independently, combining deep CMC and regulatory expertise with a practical understanding of how AI tools can genuinely improve biopharma workflows — not just on paper, but in practice.
// services
Targeted support across the CMC development lifecycle.
From early-stage strategy to regulatory submission — I provide hands-on expertise where your program needs it most, at the stage that matters.
// what I offer
CMC Strategy & Program Leadership
End-to-end CMC program ownership — DS/DP process development, analytical methods, formulation, stability, GMP readiness, and cross-functional coordination across your entire development team.
Regulatory Affairs & Dossier Support
Regulatory strategy and hands-on CMC dossier preparation for IND, CTA, and MAA submissions — with direct experience navigating EMA, FDA, and global health authority requirements.
CDMO Selection & Oversight
Identification, technical evaluation, and ongoing oversight of CDMOs and CMOs — ensuring your external manufacturing partners are held to the right standards throughout.
AI Integration in CMC Workflows
Identifying and implementing AI-driven tools within your CMC operations — process analytics, regulatory document acceleration, and decision support systems built for real-world pharma environments.
Training & Capability Building
Bespoke workshops for research and development teams — from CMC fundamentals to regulatory strategy and AI-enabled workflows. Practical, modality-specific, and immediately applicable.
Scientific Advisory
Independent technical perspective for Go/No-Go decisions, investor due diligence, and development roadmapping — from pre-IND through to commercial readiness.
// modality experience
Across the full range of therapeutic modalities.
mRNA therapeutics
Small molecules
Monoclonal antibodies
ATMPs
CRISPR / gene therapy
Orphan drugs
Cancer immunotherapy
Bacteriophage-based products
Vaccines
Biologics
// contact
Let's talk about your program.
Whether you have a specific CMC challenge, an upcoming regulatory milestone, or just want to explore what's possible — I'm happy to have an initial conversation, no strings attached.
Luka Kotrikadze
Biopharmaceutical Program Leader · Berlin
Available for consulting engagements, interim roles, advisory positions, and permanent opportunities across Europe.
