Scandinavian Regulatory Services
SRS is an established partner with over 30 years of experience in Regulatory Affairs and Quality Assurance, dedicated to helping companies bring safe and effective medicines and medical devices to market. They offer tailored solutions across pharmaceuticals, medical devices, combination products, cosmetics, and food supplements, with a focus on regulatory approvals and compliance activities in the EU/EEA and globally.
Industries
Nr. of Employees
small (1-50)
Scandinavian Regulatory Services
Services
Dossier compilation and submission, regulatory strategy, eCTD submissions, MRP/DCP coordination, lifecycle management, translations and local Nordic regulatory support.
Setup and maintenance of QA systems for GMP/GDP, QP/RP services, wholesale distribution licensing, local PV office services and PV system maintenance.
Establishment and updating of device QMS (ISO 13485 / 21 CFR 820), MDR/IVDR gap analysis, CE certification support, technical documentation, risk management and usability support.
Regulatory classification and strategy for drug‑device combinations, development of combined quality systems, coordination with notified bodies and competent authorities, and support for US FDA combination product requirements.
Safety assessments, compilation and quality assurance of Product Information Files (PIF), CPSR preparation, labeling and notification in EU portals, and compliance with Nordic legislation.
Execution of internal, supplier and joint audits, supplier evaluations, support during authority inspections and notified body audits, and audit training.
Dossier compilation and submission, regulatory strategy, eCTD submissions, MRP/DCP coordination, lifecycle management, translations and local Nordic regulatory support.
Setup and maintenance of QA systems for GMP/GDP, QP/RP services, wholesale distribution licensing, local PV office services and PV system maintenance.
Establishment and updating of device QMS (ISO 13485 / 21 CFR 820), MDR/IVDR gap analysis, CE certification support, technical documentation, risk management and usability support.
Regulatory classification and strategy for drug‑device combinations, development of combined quality systems, coordination with notified bodies and competent authorities, and support for US FDA combination product requirements.
Safety assessments, compilation and quality assurance of Product Information Files (PIF), CPSR preparation, labeling and notification in EU portals, and compliance with Nordic legislation.
Execution of internal, supplier and joint audits, supplier evaluations, support during authority inspections and notified body audits, and audit training.
Expertise Areas
- Pharmaceutical regulatory affairs and lifecycle management
- Medical device regulatory compliance and ISO 13485 QMS
- Quality assurance for GMP and GDP environments
- Pharmacovigilance and post‑market safety surveillance
Key Technologies
- eCTD electronic submissions
- Electronic quality management systems (e‑QMS)
- ISO 13485
- 21 CFR 820
News & Updates
Tamro Joint Audit Program 2025
SRS will conduct audits at Tamro locations in April and September in Kungens Kurva, Eskilstuna, and Gothenburg. Dates are 2nd April, 3rd April, and 3rd September.
EUDRACON Zagreb May 2025
SRS will participate in the EuDRAcon Conference in Zagreb in May 2025, a network of regulatory consultants across Europe.
Join Us at CPHI Frankfurt 2025!
SRS will attend the CPHI Worldwide exhibition in Frankfurt in October 2025, offering opportunities for pharmaceutical companies to connect and expand in the Nordic region.
Webinar on how and when to implement an e-QMS – May 22nd
A free webinar providing advice on implementing electronic Quality Management Systems, including benefits, considerations, and implementation strategies.
Tamro Joint Audit Program 2025
SRS will conduct audits at Tamro locations in April and September in Kungens Kurva, Eskilstuna, and Gothenburg. Dates are 2nd April, 3rd April, and 3rd September.
EUDRACON Zagreb May 2025
SRS will participate in the EuDRAcon Conference in Zagreb in May 2025, a network of regulatory consultants across Europe.
Join Us at CPHI Frankfurt 2025!
SRS will attend the CPHI Worldwide exhibition in Frankfurt in October 2025, offering opportunities for pharmaceutical companies to connect and expand in the Nordic region.
Webinar on how and when to implement an e-QMS – May 22nd
A free webinar providing advice on implementing electronic Quality Management Systems, including benefits, considerations, and implementation strategies.