AKROS BIOSCIENCE SRL

AKROS BioScience is an Italian scientific and regulatory consultancy supporting companies, universities, research organisations and innovators throughout the development of healthcare products, from early-stage concepts and non-clinical development to clinical evidence generation, regulatory documentation and market access.

Our expertise covers medical devices, medicinal products and food supplements/nutraceuticals. We combine scientific, clinical and regulatory expertise to help clients define the most appropriate development pathway, identify evidence gaps and anticipate later requirements. Our aim is to work as a development partner, not simply as a provider of individual regulatory documents.

A particular focus of our current activity is collaboration with universities, biotechnology companies, start-ups and innovative life science organisations on translational projects designed to bring promising technologies from bench to bedside. We help transform scientific concepts into structured development programmes by integrating regulatory strategy, non-clinical evidence, clinical planning and scientific communication into a coherent roadmap towards clinical application and the market.

In the medical device field, AKROS supports manufacturers throughout the product lifecycle, with particular expertise in clinical evaluation, biological evaluation, risk management, post-market clinical follow-up and clinical investigation planning. Our activities include Clinical Evaluation Plans and Reports, Biological Evaluation Plans and Reports, PMCF plans and reports, Clinical Investigation Plans, study documentation and scientific support for conformity assessment under the European regulatory framework.

Clinical research is one of our core areas of expertise. We support clinical investigations and studies, from the definition of objectives and endpoints to study design, statistical planning, investigator and site considerations, CRO selection and oversight, data interpretation and final reports. We believe that clinical evidence generation should be integrated from the outset with product development, risk management and regulatory strategy.

For medicinal products, AKROS provides support in non-clinical and clinical development planning, scientific and regulatory assessment, due diligence, Scientific Advice activities and preparation of clinical and non-clinical documentation. Our experience spans several therapeutic areas, including oncology, neurology, immunology, cardiovascular medicine, diabetology and ophthalmology.

In non-clinical development, our specialist network allows us to address pharmacology, toxicology, pathology and biological safety questions and to define programmes capable of bridging appropriately from experimental evidence to clinical use. This multidisciplinary approach is particularly valuable for innovative products for which standard development pathways may not be sufficient.

For food supplements and nutraceuticals, AKROS performs pharmacological and toxicological assessments of ingredients and formulations and supports scientific and regulatory documentation, including projects involving innovative ingredients and novel foods.

Scientific communication is another major area of activity. Our medical writers prepare scientific papers, congress abstracts, posters, presentations, literature reviews, product monographs, meeting reports and educational materials. We also support scientific positioning, literature monitoring, stakeholder analysis, surveys and consensus initiatives.

Our working model is multidisciplinary and flexible. The AKROS core team is complemented by senior professionals from academia and specialised scientific disciplines, including medicine, pharmacology, toxicology, statistics, pathology and quality. This enables us to build project teams around the specific challenges of each programme.

What distinguishes AKROS is the ability to connect the different components of development. Non-clinical evidence, clinical strategy, risk assessment, regulatory requirements and scientific communication need to tell the same scientific story. We aim to identify critical issues early, before they become obstacles during clinical development, conformity assessment or regulatory review.

At MEET in Italy for Life Sciences, AKROS BioScience is particularly interested in establishing new collaborations with universities, biotech and medtech companies, start-ups, research organisations and industrial partners developing innovative healthcare technologies. We are looking for projects where our scientific, clinical and regulatory experience can contribute from the earliest stages and help build a credible pathway from bench to bedside, from scientific concept to clinical evidence and ultimately from innovation to patients.