Akros Bioscience

Who we are

AKROS BioScience S.r.l. is a scientific and regulatory consulting company based in Pomezia, established to support healthcare companies in the development of drugs, medical devices, in vitro diagnostics, and food supplements. Our mission is to assist clients from the early research stages through to market authorization, ensuring scientific quality, regulatory compliance, and effective development strategies.

We are an independent organization, established by professionals with solid academic and industrial backgrounds. Over time, we have built a team of about ten people capable of integrating preclinical and clinical expertise within the regulatory field. This structure enables us to manage complex projects and tailor solutions to the needs of different realities: from biotech startups to established pharmaceutical companies, from medical device manufacturers to businesses operating in the nutraceutical sector.

Our company is structured into two main areas: preclinical (led by Isabella Andreini, DVM, PhD Tox., E.R.T.) and clinical (led by Salvatore Bianco, MD, Angiologist, Adjunct Professor of Medical Device Regulation and Development at Tor Vergata University). These two areas work in synergy to provide effective support in the key stages of product development. For many years, we have also collaborated with other consulting firms and preclinical and clinical CROs. We believe in a collaborative and transparent approach that allows us to build lasting, trust-based relationships with our clients and partners, always oriented toward results.

What we do

For pharmaceuticals, our services include the preparation of preclinical and clinical development plans, toxicological expertise, review of preclinical CRO protocols and reports, and the drafting of clinical study protocols and reports. We draft and submit scientific articles for publication in indexed journals. We prepare the preclinical and clinical sections of the CTD dossier and provide support to obtain Scientific Advice from Competent Authorities. We also offer strategic consultation for the presentation of
projects to potential investors, highlighting innovation and facilitating access to the capital
required for development.
For medical devices and in vitro diagnostics, we provide comprehensive consulting in line with MDR 2017/745, IVDR 2017/746, and the most up-to-date regulatory requirements (ISO standards and MDCG guidelines). Our services include the preparation of Clinical Evaluation Plans and Reports, Toxicological Risk Assessments, Biological Evaluation Plans and Reports, as well as all post-market documentation, including Post-Market Clinical Follow-up, Summary of Safety and Clinical Performance, and risk management plans.
We also apply our preclinical and clinical expertise to the development of high-quality food
supplements, supporting companies in the realization of safe, effective, and compliant
products.
Thanks to the combination of experience, scientific expertise, and regulatory knowledge,
AKROS is the ideal partner for companies aiming to transform research into concrete healthcare solutions that are safe, effective, and compliant with international regulations.