Personal and Professional
Regulatory Affairs Pharmacovigilance
Start-up? Medium-sized? Large pharma company? If you're in need of support for your developmental strategy, interactions with health authorities, coordination of procedures, writing of key documents, building of dossiers and post-approval activities...Meet with Zwiers!
In a professional way, with a personal approach
Efficient development, successful approval?
Join our 2dayRA course!
Vacancies
Regulatory CMC consultant
Experience with ATMPs/biologicals and ready to define strategy and obtain (IND, IMPD, MAA, BLA, variations) approvals ?
Local Safety Officer
Acting as local safety and pharmacovigilance representative for MAH products in the Benelux?
Regulatory Consultant Medical Devices
Development and life cycle strategy, MDR, ISO standards, QMS, technical documentation?
From study to compliance
Regulatory Affairs
We ensure that your drug is developed up to regulatory standards, results are presented in an eCTD dossier, the optimal regulatory procedure to approval is followed and authorisation is solidly maintained
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
Strategy, accuracy and quality are key
CMC
Small molecules, large molecules (biologics and vaccines) and cell and gene therapy/ATMP; Zwiers is able to support your CMC-RA needs
From DSUR to Pharmacovigilance Plan
Pharmacovigilance
Zwiers ensures no less than top quality PV across safety reporting during clinical trials, risk management, monitoring and signaling and QPPV responsibility
Accurate and compliant documents
Medical Writing
Protocols, clinical overviews and anything in between; Zwiers writes all documents related to your clinical studies and takes care of the clinical trial application as well as the subsequent CTD modules
MATURE, DYNAMIC AND CREATIVE
More than a decade experience in consultancy
Zwiers Regulatory Consultancy was founded in September 2011. Our consultancy has grown to maturity in the 10 years we have been in business. We can offer the best service by having both creative flexible young talents as well as seasoned professionals with decades of experience on board.
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.
