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Zwiers Regulatory Consultancy BV

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Year established

2011

Location

Netherlands

Primary Industry

Business Support Services

About

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.
Current Investors
Groupe ProductLife S.A.S.

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Primary Industry
Business Support Services
Sub Industries
Consulting Services, Education & Training Services
Website
www.az-regulatory.com
Company Stage
Add-on
Total Amount Raised
Subscriber access only

Financials

Fiscal Year Ended
Revenue (USD)
% Revenue Growth (YoY)
Operating Income (USD)
Operating Margin
EBITDA (USD)
% EBITDA Margin
NET Income (USD)
% Net Margin
31 Dec 2022

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Deals

Deals Type
Add-on
Deal Status Target (s) Deal Date Investor(s) Seller(s) Deal size (Mn) Enterprise value (Mn) Post-money valuation (Mn) EBITDA multiple (x) Revenue multiple (x) Lead partner (s)
Completed Zwiers Regulatory Consultancy BV 18 Oct 2022
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