From initial clinical study to post-approval compliance
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
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
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.
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.