We are pleased to inform you that AKROS Bioscience has recently obtained ISO 9001:2015 Certification for
CONSULTING SERVICES FOR THE DEVELOPMENT OF TECHNICAL DOCUMENTATION AND PUBLICATIONS FOR PHARMACEUTICALS PARAPHARMACEUTICALS AND MEDICAL DEVICES.
This is an important step in the development of the organization and further assurance for Clients on the level of quality of AKROS Bioscience’s services. We trust it will open up further possibilities for collaboration; for any further information please do not hesitate to contact us.
Companies in the field of medicines, medical devices
and food supplements need multiple and high-level skills.
These competences might be not available because they are not present in the Company or, because they are on other projects.
AKROSBIOSCIENCE
For us in AKROS BioScience professional competence comes first.
Regulatory aspects of the development of Wearable Medical Devices (Rome 2 October 2023)
AKROS Bioscience is pleased to announce the collaboration with KIWA Idea for two training courses on Medical Devices: Elevating the Safety of Medical Devices practical guide to the new ISO 10993:17 2023 (21/3/2024) e and Collecting and Evaluating Clinical Data from the Scientific Literature, Generating New Clinical Data from Clinical Investigations. (28/3/2024). This collaboration with KIWA idea is further recognition of AKROS Bioscience’s great expertise in the field of Medical Devices. For more information and registration click on the links.
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AKROS BioScience
is organized in two operational areas
Development
is dedicated to regulatory positioning; conformity and approval procedures; preparation of scientific and regulatory documentation; oversight of Non-Clinical and clinical studies; preparation of pathology, toxicology, pharmacology and clinical reports.
- Preparation of Pediatric Investigation Plan
- Risk Management Plan
- Preparation of Technical File
- Preparation of Notification Document
Communication
is committed to medical writing for scientific papers;preparation of posters and presentations;
reports of medical meetings, product monographs;
educational materials;
analysis of stakeholders.
- Analysis of scientific positioning of the product
- Review of scientific publications on the product
- Service of monitoring of new publications on the products
- Web based surveys for the evaluation of products
AKROS BioScience
relies on a team of selected collaborators with degree or PhD in life sciences and strong competence in the field.
Salvatore Bianco
CLINICAL EXPERT, CLINICAL DEVELOPMENT, SCIENTIFIC COMMUNICATION
Isabella Andreini
NON-CLINICAL EXPERT, NON-CLINICAL DEVELOPMENT.
Our social commitment
We believe that every company, regardless of its size, must be an active and positive part of society. This is why we support local cultural associations and international humanitarian institutions.
