Zwiers Regulatory Consultancy
Zwiers Regulatory Consultancy, founded in 2011, is a dynamic firm with decades of pharmaceutical industry experience, offering expertise in regulatory affairs, pharmacovigilance, and medical devices. The company is committed to providing thorough, proactive, and personalized services to support clients through the entire product lifecycle, with offices in Oss and Amsterdam. It emphasizes a professional approach with a personal touch, leveraging a strong network rooted in the Netherlands' innovative pharmaceutical hub. Zwiers has expanded its services over the years, including pharmacovigilance and medical device regulation, and has formed strategic partnerships to enhance its global reach and service offerings. The company is recognized for its expertise in regulatory strategy, submissions, and compliance, aiming to improve human health by ensuring the safe and effective use of medical solutions worldwide.
Industries
Nr. of Employees
small (1-50)
Zwiers Regulatory Consultancy
Oss, Noord-Brabant, The Netherlands, Europe
Services
Develop regulatory strategies, prepare scientific advice and pre-submission packages, define global/regional filing approaches and advise on special procedures (orphan, paediatric, accelerated pathways).
Writing, review, QC, hyperlinking, PDF publishing and compilation of eCTD-ready documents and submission management for CTAs/INDs, MAAs/BLA/NDA and variations.
Gap analyses, CMC strategy development, support for stability and specification setting, process validation control strategies, and preparation of IMPD/IND and Module 2/3 CMC sections.
Set up and operate PV systems, maintain PSMF, perform literature monitoring, manage ICSR reporting and aggregate safety reports (PSUR/DSUR), provide EU QPPV/LPPV services and PV trainings.
Conduct GVP audits, create risk-based audit plans and questionnaires, perform mock-inspections and provide inspection support.
MDR gap analysis, CE classification, technical documentation and technical file preparation, ISO 13485 QMS support, notified body interactions and post-market surveillance processes.
Develop regulatory strategies, prepare scientific advice and pre-submission packages, define global/regional filing approaches and advise on special procedures (orphan, paediatric, accelerated pathways).
Writing, review, QC, hyperlinking, PDF publishing and compilation of eCTD-ready documents and submission management for CTAs/INDs, MAAs/BLA/NDA and variations.
Gap analyses, CMC strategy development, support for stability and specification setting, process validation control strategies, and preparation of IMPD/IND and Module 2/3 CMC sections.
Set up and operate PV systems, maintain PSMF, perform literature monitoring, manage ICSR reporting and aggregate safety reports (PSUR/DSUR), provide EU QPPV/LPPV services and PV trainings.
Conduct GVP audits, create risk-based audit plans and questionnaires, perform mock-inspections and provide inspection support.
MDR gap analysis, CE classification, technical documentation and technical file preparation, ISO 13485 QMS support, notified body interactions and post-market surveillance processes.
Expertise Areas
- Regulatory affairs strategy and planning
- CMC regulatory support and quality documentation
- Pharmacovigilance and safety data management
- Medical devices regulatory compliance and ISO 13485
Key Technologies
- eCTD and electronic dossier submission
- Pharmacovigilance databases and ICSR reporting
- Regulatory intelligence and health-authority interaction workflows
- Quality Management Systems (ISO 13485)
News & Updates
In October 2022, Zwiers Regulatory Consultancy announced a strategic partnership with ProductLifeGroup to expand global coverage and reinforce development support and EU services.
In August 2023, Zwiers launched a new website to improve navigation and service discovery for clients.
In August 2021, Zwiers celebrated its 10th anniversary with a special event and continued expansion.
An analysis revealing factors impacting approval times of anticancer drugs in the EU, highlighting trends and regulatory insights.
A detailed discussion on the complexities and lessons learned from advanced therapy medicinal products (ATMP) applications in the EU.
Zwiers Regulatory Consultancy received the DIA Global Inspire Award for a paper on implementing Quality by Design principles in EU regulatory dossiers.
In October 2022, Zwiers Regulatory Consultancy announced a strategic partnership with ProductLifeGroup to expand global coverage and reinforce development support and EU services.
In August 2023, Zwiers launched a new website to improve navigation and service discovery for clients.
In August 2021, Zwiers celebrated its 10th anniversary with a special event and continued expansion.
An analysis revealing factors impacting approval times of anticancer drugs in the EU, highlighting trends and regulatory insights.
A detailed discussion on the complexities and lessons learned from advanced therapy medicinal products (ATMP) applications in the EU.
Zwiers Regulatory Consultancy received the DIA Global Inspire Award for a paper on implementing Quality by Design principles in EU regulatory dossiers.