Regulatory House
Regulatory House is a company dedicated to monitoring current legislative requirements and offering effective solutions in the regulation of medicinal products, cosmetics, veterinary products, medical devices, and food supplements. Their team of specialists provides services throughout the product lifecycle, ensuring successful registration and safety monitoring across the EU.
Industries
Nr. of Employees
small (1-50)
Regulatory House
Brno, Jihomoravsky kraj, Czech Republic, Europe
Services
End-to-end clinical trial support including study design, site selection, monitoring, data management, biostatistics, medical writing, regulatory support and pharmacovigilance.
Regulatory strategy development, preparation of registration/notification dossiers and support for market authorizations across medicinal, veterinary, medical device, cosmetic and food supplement categories in the EU.
Establishment and maintenance of vigilance systems, safety monitoring and regulatory reporting for marketed products in the EU.
Development of SOPs, implementation of QA/QC systems and performance of GCP and quality audits to support compliance.
Advisory services to align preclinical and early clinical development with regulatory requirements and market-entry planning.
Provision and facilitation of training courses and seminars on GCP, clinical trial conduct and pharmacology.
End-to-end clinical trial support including study design, site selection, monitoring, data management, biostatistics, medical writing, regulatory support and pharmacovigilance.
Regulatory strategy development, preparation of registration/notification dossiers and support for market authorizations across medicinal, veterinary, medical device, cosmetic and food supplement categories in the EU.
Establishment and maintenance of vigilance systems, safety monitoring and regulatory reporting for marketed products in the EU.
Development of SOPs, implementation of QA/QC systems and performance of GCP and quality audits to support compliance.
Advisory services to align preclinical and early clinical development with regulatory requirements and market-entry planning.
Provision and facilitation of training courses and seminars on GCP, clinical trial conduct and pharmacology.
Expertise Areas
- Regulatory affairs and market authorization (EU)
- Pharmacovigilance and vigilance systems
- Clinical trial management and monitoring
- Clinical data management and biostatistics
Key Technologies
- Clinical trial data management systems
- Biostatistical analysis methods
- Electronic clinical trial submission systems (CTIS/electronic dossiers)
- Regulatory intelligence monitoring tools
News & Updates
The European Commission is preparing a public consultation document for Q3 2024 to assess the effectiveness and added value of new rules for medical devices and diagnostics.
The European Commission is preparing a public consultation document for Q3 2024 to assess the effectiveness and added value of new rules for medical devices and diagnostics.