trilenda

CMC reimagined.
Statistics meets AI.

trilenda is a Belgian consulting company at the intersection of deep pharmaceutical statistics and modern AI. We help biopharma teams tackle CMC challenges with the rigor of 30 years of applied statistics and the tools of today's data science.

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01 / About
Who we are

Two disciplines
under one roof.

trilenda was co-founded by Bruno and Nils Boulanger to bring together two fields that rarely sit side by side: deep pharmaceutical statistics and modern AI/ML engineering.

The result is a consulting practice built for today's CMC reality, where regulatory rigor, automation, and AI readiness need to work together.

02 / Expertise
  1. 01

    CMC Statistics

    Method validation, bioassay qualification, method transfer, stability, specification setting, process performance. The full statistical scope of analytical and manufacturing QC, from early development through commercial lifecycle.

  2. 02

    CMC Automation

    Lab workflows, instrument integration, data pipelines, automated reporting. We replace manual, error-prone processes with systems that scale and stay compliant.

  3. 03

    AI for Life Sciences

    Predictive quality models, process optimization, intelligent lab systems. We make AI work inside regulated environments, not around them.

  4. 04

    Clinical Statistics

    Bayesian trial design, adaptive methods, rare disease programs, real-world evidence. The same statistical depth we bring to CMC, applied to your clinical development.

  5. 05

    Training

    Method validation, bioassay statistics, stability, experimental design. Practical workshops built around your team's real problems. On-site, remote, or tailored.

03 / Software
Statistical suite
Available soon

Software for
regulated CMC.

21 CFR Part 11 qualified. ICH-aligned. Submission-ready. Four modules covering method validation, bioassay, method transfer, and stability.

M01

Method Validation

Prove your analytical method measures what it should. ICH Q2(R2), Q14, M10, USP ⟨1210⟩.

M02

Bioassay Validation

Trustworthy potency across ELISA, cell-based, qPCR, parallel-line and slope-ratio. USP ⟨1032⟩-⟨1034⟩.

M03

Method Transfer

Quantify the OOS risk at the receiving lab before transfer. All four USP ⟨1224⟩ approaches.

M04

Stability

Shelf life, release limits, early trend detection. Aligned with ICH Q1E and the new consolidated ICH Q1.

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04 / Approach
  1. A.

    Where CMC statistics
    meets AI.

    Decades of pharmaceutical development plus modern data science. The combination is rare, and it lets us solve problems that pure statisticians or pure technologists cannot tackle alone.

  2. B.

    Regulatory depth,
    not just compliance.

    14 years on the USP Committee on Statistics. 130+ peer-reviewed publications. A track record of shaping how the industry thinks about measurement uncertainty, method validation, and stability.

  3. C.

    Small team,
    real accountability.

    When you work with trilenda, you work directly with the people doing the thinking. No layers. No hand-offs.

05 / Team
Founders & team

Three people.
Real depth.

Bruno Boulanger, CEO and Scientific Director at Trilenda — pharmaceutical statistician, former USP Committee on Statistics member

Bruno Boulanger

CEO & Scientific Director

30+ years in applied statistics across Eli Lilly and UCB. Founder of Arlenda (2003). USP Committee on Statistics 2010-2024. 130+ peer-reviewed publications. Co-founder of Sanaitio.

LinkedIn
Nils Boulanger, CTO at Trilenda — data scientist and AI engineer for CMC and life sciences

Nils Boulanger

CTO

Data scientist and AI engineer. Predictive quality models, process optimization, and intelligent lab systems for CMC. Co-founder of Sanaitio.

LinkedIn
Gaëlle Martin, Head of Quality Assurance at Trilenda — GMP, GCP, GAMP5 and ISO 9001/13485 specialist

Gaëlle Martin

Head of QA

20+ years in QA leadership. QMS aligned with GMP, GCP, GAMP5, ISO 9001/13485. Computerized system validation and complex GxP projects.

LinkedIn
06 / Contact
Get in touch

Bring us the problem.
We'll bring the solution.

Send a note about what you're working on. We'll get back within a couple of working days.