our consultancy services
Every project is different. With our consultancy services, we adapt to your needs, helping you turn scientific vision into clinical reality.
Translational Strategy & Program Design
From concept to clinical plan
We help transform scientific discoveries into structured development programs.
Our team supports early-stage projects in defining translational objectives, critical experiments, and milestones that align with clinical and regulatory expectations.
We bring hands-on experience from multiple cell-therapy programs to ensure each step builds toward a viable therapeutic product.
protocol design · pluripotent stem-cell biology · differentiation workflows · potency assays · in vivo pharmacology · biomarker strategy · regulatory scientific advice meetings
Process Development & CMC Strategy
Bridging science and manufacturing
We guide clients in developing scalable, reproducible, robust, and GMP compliant manufacturing processes, with focus on reducing COGS. Based on the Quality by Design approach, we can help you define your Quality Target Product Profile, Critical Quality Attributes, release specifications, raw material risk assessments, and the overall product risk assessment. We can help design your analytical qualification programs, including writing protocols and reports, and if
needed execute the study on your behalf. Whether your ambitions are fast to first human dose or fast to market, we can guide your strategies accordingly. We ensure that your production platform is ready for clinical and regulatory scrutiny.
process design · 2D & 3D upscaling · formulation & cryopreservation · raw-material strategy · QA / QMS · CDMO selection & oversight · delivery device
Non-Clinical & Regulatory Guidance
De-risking the path to first-in-human
We design and interpret non-clinical studies that demonstrate safety, potency, and mechanism of action. Our consultants help translate data into regulatory-ready packages and align study plans with global requirements. We also support clients in preparing regulatory documentation and engaging effectively with authorities.
study design · histology · pharmacology · CRO selection · IND / CTA strategy · regulatory documentation · biomarker integration
Clinical & Operational Support
From the lab to the clinical site
We help coordinate the first steps of clinical implementation, ensuring alignment between CMC, regulatory, and clinical teams.
Our services include all steps from clinical trial design to clinical supply mapping and coordination, as well as final qualification of the on-site dosing process. We will ensure that your secondary endpoints, stopping rules and follow-up programs are compliant with regulators expectations. We work closely with CDMOs and clinical partners to maintain quality and consistency through every stage.
site initiation & dosing support · person-in-plant supervision · due diligence · trial design · clinical supply · risk management · quality monitoring
Intellectual Property & Business Development
Turning science into sustainable impact
We assist companies and academic spin-offs in building partnerships, communicating with investors, and planning for long-term growth.
Our team combines scientific insight with strategic perspective to help position your technology for clinical and commercial success.
patents · business strategy · partnerships · market positioning · investor communication
Emerging Technologies
Preparing for what comes next
Innovation drives progress in cell therapy. We help clients evaluate and integrate new technologies, from genome engineering and device development to automation and data-driven manufacturing, always with quality and compliance in mind.
genome editing · automation · device integration · combination products
core expert associates
Ida Kjær
SENIOR CONSULTANT | CMC SPECIALIST
Ida Kjær is a Senior Consultant and CMC specialist with extensive experience in quality systems, GMP strategy, raw materials, and late-stage process development for cell-based therapies. Her expertise includes GTP compliance, formulation and packaging systems, and clinical readiness for advanced therapies.
Tristan Thwaites
SENIOR CONSULTANT | CELL & GENE THERAPY DEVELOPMENT
Tristan Thwaites is a Senior Consultant with more than 15 years of experience advancing genome-edited and stem cell–based therapies from research to clinical translation. His expertise spans CRISPR technologies, CMC readiness, and cross-functional leadership across biotech and pharma.
Jan Lynge
SENIOR CONSULTANT | CLINICAL & REGULATORY STRATEGY
Jan Lynge is a Senior Consultant with expertise in stem cell–derived therapies, clinical development strategy, and ATMP regulatory pathways. He has extensive experience supporting translational medicine, First-in-Human studies, due diligence, and portfolio strategy.
Elizabeth Engenheiro Kristiansen
SENIOR CONSULTANT | INTELLECTUAL PROPERTY STRATEGY
Elizabeth Engenheiro Kristiansen is a Senior Consultant with more than 17 years of experience advising life science organizations on intellectual property strategy, patent protection, and portfolio development across cell and gene therapy technologies.
Chao Sheng
SENIOR CONSULTANT | ATMP STRATEGY & MARKET ANALYSIS
Chao Sheng is a Senior Consultant with over 17 years of experience across academia, biotech, and CDMO environments. His expertise includes ATMP market analysis, product strategy, and strategic positioning of emerging cell and gene therapy technologies.
Elhem Sbaa
SENIOR CONSULTANT | REGULATORY AFFAIRS & ATMP DEVELOPMENT
Elhem Sbaa is a Senior Consultant with over 17 years of experience in regulatory affairs across biologics, ATMPs, and medical devices. Her expertise spans regulatory strategy, clinical translation, market authorization, and advanced therapy development in Europe and the US.
Joachim Hjelm
SENIOR CONSULTANT | GLOBAL REGULATORY STRATEGY
Joachim Hjelm is a Senior Consultant with more than two decades of experience in global drug development and regulatory strategy across cell therapies, biologics, peptides, and combination products. He has extensive experience engaging with health authorities across major international markets.
Eric Thwaites
SENIOR CONSULTANT | CMC & MANUFACTURING STRATEGY
Eric Thwaites is a Senior Consultant with over 20 years of experience in biopharma and cell therapy development, including CMC strategy, manufacturing, and commercialization. He played a key role in bringing the first allogeneic mesenchymal stem cell therapy (Alofisel®) to market.
Kan Kaneko
CONSULTANT | DELIVERY & COMBINATION PRODUCTS
Kan Kaneko is a Consultant with expertise in delivery systems, formulation strategies, and combination-product development for cell-based therapies. His work focuses on optimizing administration, stability, and translational usability of advanced therapies.
Anna Drozd
CONSULTANT | RAW MATERIALS & SUPPLY STRATEGY
Anna Drozd is a Consultant specializing in raw materials strategy and qualification for cell-based therapies. Her expertise includes supplier evaluation, risk assessment, and phase-appropriate compliance for advanced therapy manufacturing.
Peter Overby
CONSULTANT | PRECLINICAL & TRANSLATIONAL DEVELOPMENT
Peter Overby is a Consultant with expertise in diabetes, metabolism, and stem cell–based therapies. He has extensive experience in preclinical models, translational assessments, and non-clinical development supporting advanced therapeutic programs.
