Zwiers Regulatory Consultancy BV

Based in Oss, Netherlands, and founded in 2011 by CEO Alex Zwiers, Zwiers Regulatory Consultancy BV, a. k. a. Zwiers Regulatory Consultancy operates as a provider of consulting services that focuses on regulatory affairs, pharmacovigilance, and integrated development for pharmaceutical product development from initial clinical trial application to post-marketing compliance.

In October 2022, Groupe ProductLife S. A. , a portfolio company of 21 Invest, acquired Zwiers Regulatory Consultancy. The company provides a wide range of support services, including Health Authority Interactions like advice, documentation, coaching, and responses; operational like legal entity changes, manufacturing changes, due diligence, variations, and CTAs; labeling like SPC, CCDS, and PIL; strategy, opportunity, and action support to startups; eCTD Reports and Submissions; compliance of documentation and QMS with the relevant ISO standards, directives, regulations, and guidance documents for medical devices/IVDs; pharmacovigilance like GPV compliant procedures and databases; and scientific advice, long term strategy plans, orphan designations, pediatric investigations, and regulatory writing.

Zwiers Regulatory Consultancy also provides a training program, which is regulatory affairs from A to Z, enabling individuals to gain knowledge on the essentials of regulatory affairs.