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
Regulatory and Pharmacovigilance Experts

Logo Woord

3&4 October

Efficient development, successful approval?

Join our 2dayRA course!

 

Webinar on PRIME scheme

July 30th

Unmet medical need? Learn how to use PRIME scheme to ensure your product reaches patients as soon as possible. Interested to hear more about the eligibility criteria and the PRIME scheme procedure?

 

Vacancies

Local Safety Officer

Acting as local safety and pharmacovigilance representative for MAH products in the Benelux?

Experienced Regulatory Consultant Medical Devices

Development and life cycle strategy, MDR, ISO standards, QMS, technical documentation?

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Medical Writing
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.
OUR OFFICES

Meet with Zwiers!

Visit our offices in Oss (2' from railway station) or Amsterdam (Health Innovation District) or simply send us an email. We look forward to it!
info@az-regulatory.com
Call us
+31 (0) 6 344 848 51
Gasstraat 20 5349 AA Oss Netherlands
HID Campus Plesmanlaan 125 1066 CX Amsterdam Netherlands
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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.

Product LIfe Group