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Scientific Advisory
Scientific Advisory
Scientific Advisory
ARC supports teams across biopharma and regulated industries in generating, evaluating, and positioning data so it holds up where it matters — in development, regulatory review, and investment decisions.
About ARC
ARC works 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. We were 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.
What we do
Four areas of scientific advisory, each grounded in judgment and shaped by an understanding of how data needs to function in real development, regulatory, and investment decisions.
Assessment and justification of chemical safety across products and processes — impurities, E&L, nitrosamines, and active substances. Integrates literature, in silico, and NAMs.
For teams navigating CMC changes, formulation decisions, or regulatory questions on impurity and degradation profiles.
Scientific evaluation of environmental risk based on available evidence. ERA Phase I & II, data gap analysis, justified waiving, and study design guidance.
For developers of human medicinal products working through EMA environmental requirements.
Independent scientific oversight at the points where it makes the most difference: study design, protocol review, report evaluation, and integration into regulatory submissions.
For sponsors who want an experienced second pair of eyes on what their CROs deliver.
Integrates safety, sustainability, and development considerations into a single decision frame — connecting early choices with their downstream regulatory consequences.
For programs where early choices need to hold up against later scrutiny.
Support for research institutions positioning capabilities as structured, industry-ready services — or designing programs with regulatory and market demands in view.
For academic groups and core facilities that want their scientific output to travel beyond publication.
The team
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.
Anchors ARC’s human and environmental safety work. Brings mechanistic insight, weight-of-evidence reasoning and data-driven decision support.
Background in Chemical Engineering and Molecular Biology, PhD in Molecular Biology. Expertise in disease mechanisms, genome instability, and genotoxicity. Several years in regulatory toxicology and non-clinical consulting within the pharmaceutical sector.
Anchors ARC’s translational development advisory. Connects early experimental choices with their downstream safety, regulatory, and sustainability implications.
PhD in Biotechnology from NTUA, MSc in Structural Biology from University of Edinburgh. Publications in Nature Biomedical Engineering and Science Advances. Background spans protein engineering, high-throughput drug discovery, and environmental biotechnology.
Anchors ARC’s chemistry-side support for CMC-adjacent decisions, impurity assessment, and formulation questions. Brings REACH, GMP, and industrial R&D experience.
PhD in inorganic chemistry and crystallography, University of Crete. REACH dossiers, GMP conditions, ISO-based quality framework. Research collaborations across European institutions.
Anchors ARC’s non-clinical study oversight and drug discovery support. Brings high-throughput experimentation, protein science, and quality-system experience.
Research Associate at NHRF/BSRC Alexander Fleming since 2019. Former CSO at a Greek life-sciences company — GMP and ISO 9000 implementation, cross-functional team leadership.
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.
Get in touch
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.