Do you assist with product or device registration?
Yes. At Biostat®, we support sponsors, manufacturers and marketing authorisation holders in the full registration process of medicinal products and medical devices — both at national and European levels.
Registration requires scientific, regulatory and operational expertise. Working with us ensures comprehensive support, including:
• Design and execution of clinical studies for regulatory submissions.
We prepare the study concept, protocol and statistical analysis plan in line with EMA, URPL and FDA requirements. We manage the entire process from planning to the Clinical Study Report (CSR), ensuring compliance with ICH GCP, EU Regulation 536/2014 and MDR 2017/745.
• Preparation of clinical documentation for registration dossiers.
We develop the clinical sections of CTD Module 5 and prepare Clinical Evaluation Reports, summaries of clinical data, safety and efficacy analyses — all compliant with EMA guidelines.
• Preparation of Clinical Evaluation Reports (CER) and SSCP for devices.
We prepare CER and SSCP documents in accordance with MDR Annex XIV and XV. We analyse clinical data from literature, registries and sponsor’s own studies to demonstrate safety and performance.
• Support in communication with notified bodies and regulatory authorities.
We assist in drafting responses to authority questions, updating documentation and providing scientific justification. We participate in Scientific Advice meetings and national authority consultations.
• Analysis of existing clinical data.
We perform systematic reviews and meta-analyses for registration updates, renewals or indication extensions.
Our experience covers a wide range of therapeutic areas (oncology, cardiology, neurology, dermatology, rare diseases) and device classes (I–III).
This allows us to tailor evidence strategies for products of varying complexity.
Biostat® ensures that your documentation is coherent, transparent and meets regulatory expectations — increasing the likelihood of successful market authorisation.
