Our services go beyond providing a document or report
Why Zwiers?
- We’re proactive, communicative, experienced and personal in our approach
- We smooth the regulatory pathway both strategically as well as at an operational level
- We serve you and your patients
Our expertise covers the entire pharmaceutical product development and life cycle
Want to bring your project to the next level?
Meet with Zwiers! Contact us
From initial clinical study to post-approval compliance
Regulatory Affairs
We ensure your drug is developed up to regulatory standards, your results are presented in a submission ready eCTD dossier, the optimal regulatory prodcedure to approval is followed and authorisation is solidly maintained and extended.
From DSUR to Pharmacovigilance Plan
Pharmacovigilance
Safety reporting during clinical trials, risk management, monitoring and signaling, QPPV responsibility: the professionals of Zwiers have the experience and skills to ensure no less than top quality PV
From Standard to CE mark
Medical Devices
Zwiers ensures compliance of documentation and QMS with the relevant ISO standards, Directives, MDR and Guidance Documents. For your medical devices, combination/borderline products or IVDs.
We have offices in Oss and Amsterdam
Zwiers Regulatory Consultancy is a ProductLifeGroup Company
ProductLife Group’s mission is to improve human health by delivering regulatory & compliance services for the safe and effective use of medical solutions. PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 150 countries.
