Full regulatory and pharmacovigilance support for medicinal products and medical devices. Zwiers Regulatory Consultancy provides your company with quality support, throughout the entire drug lifecycle.
From initial clinical trial application to post-marketing compliance.
For medicinal products and medical devices
Our services include:
- Regulatory strategic advice
- Risk management and pharmacovigilance
- Writing, reviewing and compiling of regulatory documents
- Regulatory intelligence and training
Area of work
Consultancy, Regulatory affairs, Pharmacovigilance, Global
Services and products
- Labeling: product information, target product profile
- Health authority interactions: scientific advice, pre-submission, notified bodies
- Pharmacovigilance: risk management, periodic reporting, signaling, literature
- Product maintenance: life cycle management, variations
- Regulatory strategy: intelligence, competitors, planning
- Support to start ups: orphan drugs, accelerated approval, adaptive pathways
- Reports and submissions: medical and regulatory writing, reviewing, clinical trial applications, Policy 70
- Medical devices: technical file, biological and clinical evaluation, ISO, CE classification
Zwiers is always looking for skilled professionals ready for a new challenging opportunity. Check out our vacancies. Show us your enthusiasm and competence by contacting us. We’ll get back to you as soon as possible.
Learn and Work program: 6 months of training and on-the-job learning at Zwiers with the ultimate goal of obtaining a job position at Zwiers or mediated by Zwiers Regulatory Affairs for A to Z: 4 weeks introduction course to quickly gain knowledge on the essentials of Regulatory Affairs and get a taste of the regulatory job.
Zwiers was one of the first companies to settle in Pivot Park. In this way the company could contribute to and benefit from the Life Sciences Community.