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.
The contents of this website have been prepared with great care. However, no guarantee can be given for the accuracy, completeness, or timeliness of the content. As a service provider, Luka Kotrikadze is responsible for own content on this website in accordance with general legislation (§ 7 TMG). According to §§ 8–10 TMG, there is no obligation to monitor transmitted or stored third-party information.
// liability for links
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// copyright
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