From early development, to investment and regulatory decisions, ARC provides the independent scientific expertise those decisions require. Founded by scientists who have done the work.
Rigorous science. Practical judgment.
Product Safety and Quality · Environmental Risk Assessment · Non-Clinical Development and Regulatory Support · Translational Development Advisory · Research-to-Industry Translation
Biopharma, Biotech, MAHs, CDMOs and manufacturers · Research institutions and consortia · Partner organisations and CROs
Scientists with combined experience across academic research and regulated industries
ARC is a science-driven advisory operating at the interface of human and environmental safety, product development, and sustainability. We work with teams that need scientific judgment applied to real decisions — not just data, but data interpreted with proportionality, context, and an understanding of what comes next.
Five areas of scientific advisory, each grounded in judgment and shaped by an understanding of how evidence supports development, regulatory, and investment decisions.
Assessment and justification of chemical safety across products and processes, including impurities, extractables and leachables, nitrosamines, and active substances. Integrates literature, in silico methods, and ΝΑΜs to support robust, exposure-based decisions in development and manufacturing contexts.
For teams addressing chemical safety, quality, and CMC-related questions across raw materials, formulations, and manufacturing processes.
Scientific evaluation of environmental risk based on available evidence. Includes literature-based evaluation, data gap analysis, and scientifically justified waiving approaches, as well as guidance on study design, where additional data are required.
For organisations addressing environmental risk requirements.
Independent scientific advice on non-clinical strategy, study design, evidence evaluation, and regulatory readiness. Covers programme planning, critical review of data packages, due diligence, and IND-enabling support.
For organisations whose development or investment decisions depend on the strength of the underlying non-clinical evidence.
Supporting the transition from scientific discovery to product development by shaping early-stage strategies and proof-of-concept plans. Focuses on designing and integrating experimental and computational approaches to generate data that can support development progression and early decision-making, with sustainability considerations integrated where relevant.
For programmes where early choices need to hold up against later scrutiny.
Support for research institutions seeking to position their capabilities as structured, industry-ready services, or to design research programmes with downstream regulatory, market, and sustainability demands already in view.
For academic groups, core facilities, and research infrastructures that aim for their scientific output to travel beyond publication.
ARC was founded by scientists who saw a recurring gap between how data is generated and how it needs to function in development, regulatory, and investment decisions. The combined experience behind ARC spans academic research and regulated industries, shaping an approach that is rigorous in method, realistic about constraints, and focused on what makes evidence actionable.
Anchors ARC’s work on non-clinical development, toxicological risk assessment, and regulatory strategy. Brings the ability to integrate mechanistic understanding, non-clinical evidence, and regulatory requirements into scientifically robust safety assessments and development decisions.
Maria has a background in Chemical Engineering and Molecular Biology, and holds a PhD in Molecular Biology. Her work has focused on disease mechanisms, genome instability, and genotoxicity, providing a strong mechanistic foundation for the evaluation and interpretation of toxicological data.
She works in regulatory toxicology and non-clinical consulting within the pharmaceutical sector, focusing on the assessment of non-clinical data, the integration of diverse evidence streams including in silico approaches and ΝΑΜs, and the development of scientifically justified safety and regulatory strategies. Her experience includes contributions to human health and environmental risk assessments, non-clinical development programmes supporting IND and marketing authorisation filings, and the preparation and critical review of regulatory documentation. Her work involves the evaluation of non-clinical data packages and the development of scientifically robust narratives that support regulatory decision-making throughout product development.
At ARC, she supports the translation of complex non-clinical evidence into scientifically robust strategies that guide product development, regulatory interactions, and safety decision-making.
ARC’s biotechnology-side support for drug discovery and protein engineering, early-stage experimental design, and multi-stakeholder translational decisions. Brings high-throughput screening, nanocarrier development, and structural biology experience.
Ilias brings a hands-on biotechnology and protein engineering perspective to ARC’s translational development work. During his postdoctoral research, he has worked on high-throughput drug discovery for protein misfolding diseases, albumin-based nanocarrier development, and environmental biotechnology focused on cyanobacteria. He also contributed to establishing an industry–academia consortium between a Greek adhesives manufacturer and two Athens universities.
He holds a PhD in Biotechnology from the National Technical University of Athens and previously completed an MSc by Research in Structural Biology at the University of Edinburgh. He continues to collaborate on structural biology research at the National Hellenic Research Foundation.
At ARC, he focuses on screening assay and protein engineering questions, experimental design choices at the bench-to-development interface, and translational input on cross-institutional research programmes.
Anchors ARC’s chemistry-side support for CMC-adjacent decisions, impurity assessment, and formulation questions. Brings REACH, GMP, and industrial R&D experience.
Dimitris brings an industrial R&D perspective to ARC’s work on the chemistry and CMC side. As Chemical Manager at a Greek adhesives manufacturer, he oversees formulation development and industrial R&D under GMP conditions, has prepared REACH dossiers, and has led restricted-substance policies within an ISO-based quality framework. His PhD is in inorganic chemistry and crystallography from the University of Crete, with research collaborations across European institutions and a publication record in coordination chemistry. This combination makes him the natural point of contact at ARC for impurity and degradation questions, formulation-related safety issues, and interfaces with CMC decisions.
Maria has a background in Chemical Engineering and Molecular Biology, and holds a PhD in Molecular Biology. Her work has focused on disease mechanisms, genome instability, and genotoxicity, providing a strong mechanistic foundation for the evaluation and interpretation of toxicological data.
She works in regulatory toxicology and non-clinical consulting within the pharmaceutical sector, focusing on the assessment of non-clinical data, the integration of diverse evidence streams including in silico approaches and ΝΑΜs, and the development of scientifically justified safety and regulatory strategies. Her experience includes contributions to human health and environmental risk assessments, non-clinical development programmes supporting IND and marketing authorisation filings, and the preparation and critical review of regulatory documentation. Her work involves the evaluation of non-clinical data packages and the development of scientifically robust narratives that support regulatory decision-making throughout product development.
At ARC, she supports the translation of complex non-clinical evidence into scientifically robust strategies that guide product development, regulatory interactions, and safety decision-making.
Ilias brings a hands-on biotechnology and protein engineering perspective to ARC’s translational development work. During his postdoctoral research, he has worked on high-throughput drug discovery for protein misfolding diseases, albumin-based nanocarrier development, and environmental biotechnology focused on cyanobacteria. He also contributed to establishing an industry–academia consortium between a Greek adhesives manufacturer and two Athens universities.
He holds a PhD in Biotechnology from the National Technical University of Athens and previously completed an MSc by Research in Structural Biology at the University of Edinburgh. He continues to collaborate on structural biology research at the National Hellenic Research Foundation.
At ARC, he focuses on screening assay and protein engineering questions, experimental design choices at the bench-to-development interface, and translational input on cross-institutional research programmes.
Anchors ARC’s chemistry-side support for CMC-adjacent decisions, impurity assessment, and formulation questions. Brings REACH, GMP, and industrial R&D experience.
Dimitris brings an industrial R&D perspective to ARC’s work on the chemistry and CMC side. As Chemical Manager at a Greek adhesives manufacturer, he oversees formulation development and industrial R&D under GMP conditions, has prepared REACH dossiers, and has led restricted-substance policies within an ISO-based quality framework. His PhD is in inorganic chemistry and crystallography from the University of Crete, with research collaborations across European institutions and a publication record in coordination chemistry. This combination makes him the natural point of contact at ARC for impurity and degradation questions, formulation-related safety issues, and interfaces with CMC decisions.
Anchors ARC’s non-clinical study oversight and drug discovery support. Brings high-throughput experimentation, protein science, and industrial quality-system experience.
Aristeidis brings over a decade of combined experience across laboratory research and industrial scientific operations. Since 2019, he has worked as a Research Associate in the Skretas group at the National Hellenic Research Foundation and BSRC “Alexander Fleming,” designing and executing high-throughput cell-based drug discovery assays targeting protein misfolding diseases, including the identification and validation of cyclic peptide candidates against therapeutic targets. Earlier, as Chief Scientific Officer at a Greek life-sciences company, he led scientific and regulatory affairs, managed a cross-functional team across QA, QC, production, and R&D, and implemented GMP and ISO 9000 standards. This combination of hands-on experimental depth and industrial quality-system experience underpins his contribution to ARC’s study design review and non-clinical study oversight work.
The combined experience behind ARC spans academic research and regulated industries, shaping an approach that is focused on what makes evidence actionable — not just data generation.
Every assessment is built on proportionality, context, and an understanding of what the data needs to do next.
Our team reads across chemistry, toxicology, biotechnology, and regulatory science — questions at intersections get answered properly.
We understand how evidence functions in development, regulatory review, and investment decisions — and we structure it accordingly.
If any of this maps to yours, we’d be glad to talk it through. Tell us where yours is, and we’ll tell you whether we can help.
