Strategic Regulatory Consultation Support for the Development of Pharmaceuticals and Medical Devices

Identifying and applying the right regulatory requirements during the development of pharmaceuticals and medical devices presents a significant challenge in the pharmaceutical sector in Europe, especially for young companies and small and medium-sized enterprises (SMEs).

To address this, JOANNEUM RESEARCH and BNN, represented by Karin Pickl and Daníel Garcia, respectively, have joined forces to offer a specialized and comprehensive service. The support covers the guidance and advice on regulatory matters for the development of pharmaceuticals, nanomedicines, in vitro diagnostics (IVDs), and medical devices, including Software as a Medical Device (SaMD), focusing on providing tailored solutions to companies at various stages of the product development.

For pharmaceuticals, early strategic regulatory planning is key to gaining investor confidence and advancing development efficiently. The support includes a broad variety of topics, from gap analysis and strategic roadmaps to identify regulatory and experimental requirements, ensuring alignment of milestones with time and cost projections, to facilitation of interaction with key regulatory authorities, such as the FDA, EMA, and European agencies, to validate and refine development plans.

For medical devices, the support addresses the complexities of compliance with the Medical Device Regulations (MDR) 2017/745, 746, and standards such as EN ISO 13485 and EN 62304 for SaMD. It offers foundational training through workshops and interactive sessions, helping startups and innovators understand the basic regulatory requirements, assess risk management, and classify products effectively. The service provides strategic support, including gap analysis, mock audits, quality management system implementation and guidance in technical documentation preparation. It also supports the execution of clinical studies, covering protocol design, data management, statistics, and medical writing, all in compliance with Good Clinical Practice (GCP).

With extensive individual experience, this collaboration seeks to combine the knowledge and expertise of both organizations to offer a comprehensive service that ensures SMEs can effectively navigate complex regulatory environments.

To take advantage of these services, contact daniel.garcia@bnn.at  and karin.pickl@joanneum.at