Zwiers very much appreciates having met with Rob Haselberg (Vereniging van Huntington) who presented to the team on Huntington’s Disease. Not only did he give a good overview of the science and the clinical signs, but he also made us very aware of the enormous impact this rare disease has on the lives of patients, possible carriers and their beloved ones. With no cure available, he pointed out the urgency of drugs currently in development making it to the market. Zwiers is determined to contribute to that goal! www.az-regulatory.com
Zwiers Regulatory Consultancy BV
Geneesmiddelenproductie
Oss, Noord-Brabant 1.172 volgers
Zwiers RA and PV specialists: proactive, communicative, experienced and personal
Over ons
Zwiers Regulatory Consultancy provides full regulatory support, throughout the entire drug lifecycle. From initial clinical trial application to post-marketing compliance, from A to Z. Our services include: - Regulatory strategic advice - Writing, reviewing and compiling of regulatory/PV documents and eCTDs - Regulatory intelligence and training For more information: Alex Zwiers, CEO Tel: +31 (0)6 10489150 info@az-regulatory.com www.az-regulatory.com
- Website
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http://www.az-regulatory.com
Externe link voor Zwiers Regulatory Consultancy BV
- Branche
- Geneesmiddelenproductie
- Bedrijfsgrootte
- 11 - 50 medewerkers
- Hoofdkantoor
- Oss, Noord-Brabant
- Type
- Particuliere onderneming
- Opgericht
- 2011
- Specialismen
- Regulatory Affairs, Medicinal products, Medical devices, Pharmacovigilance, Writing, Project management, eCTDs en Strategy
Locaties
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Primair
Routebeschrijving
Gasstraat 20
Oss, Noord-Brabant 5349 AA, NL
Medewerkers van Zwiers Regulatory Consultancy BV
Updates
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Meet with Zwiers on November 26th! Are you working on a Drug-Device combination? And planning to submit it as medicinal product in the EU? Find out how to comply with the Medical Device Regulation and Article 117; join our webinar! Register directly via https://lnkd.in/ehY3ZBTY or check out www.az-regulatory.com
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Last week Zwiers had the opportunity to interview Irma, who was diagnosed with Parkinson's disease in 2012. She and her husband Paul, both very active in the “Parkinson's community,” not only made it clear that the symptoms include much more than the commonly known tremors, stiffness, akinesia and imbalance, see also https://lnkd.in/epevGXVd. Moreover, they also indicated that, even with Parkinson's disease, it is still possible and highly desirable(!) to be active and “fit.” Zwiers thanks Irma and Paulus for inspiring us to continue working full force in the search for good medication that can contribute to this.
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Are you planning a clinical trial, but struggling with the newly implemented rules of the Clinical Trial Regulation (and its quickly approaching implementation deadline 😉)? Join our webinar to learn about the features of the Clinical Trial Information System (CTIS) and ensure timely submission of your clinical trial applications and/or transitions. Register via https://lnkd.in/efwQHqwB and/or check out: www.az-regulatory.com
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Interested to learn how to deal with notified body audits and technical assessments? Join the webinar! With Zwiers contribution 😉 ! [Free Webinar 🎧] 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗳𝗲𝗲𝗱𝗯𝗮𝗰𝗸 𝗳𝗿𝗼𝗺 𝗡𝗕 𝗔𝘂𝗱𝗶𝘁𝘀 𝗮𝗻𝗱 𝘁𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗮𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁: 𝗼𝘂𝗿 𝗯𝗲𝗻𝗰𝗵𝗺𝗮𝗿𝗸 𝗼𝗳 𝗯𝗲𝘀𝘁 𝗽𝗿𝗮𝗰𝘁𝗶𝗰𝗲𝘀 📅 Date & Time: October 10, 2 PM CET 🎟️ Register here: https://lnkd.in/dw8zdWyD
LinkedIn
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Meet with Zwiers! Are you the Regulatory CMC expert we’re looking for? Do you have experience with ATMPs/biologicals and are you ready to define strategy and obtain (IND, IMPD, MAA, BLA, variations) approvals? Check https://lnkd.in/e4Ehhprm and apply to use your solid Pharmacy/Chemistry/Life Sciences background, writing and communication skills to the max while working in our dynamic and enjoyable team!
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We're #hiring a new Regulatory Affairs CMC Consultant in Oss, North Brabant. Apply today or share this post with your network.
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Meet with Zwiers on September 19th! Learn how the reformed Pharmaceutical Legislation changes regulatory incentives and procedures in general and more particularly for paediatrics and orphan drugs. Find out how this may affect your drug development, regulatory approval and maintenance? Check out www.az-regulatory.com or register directly via https://lnkd.in/eD9EaCnd
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❕ Limited number of places available! Get to know all about regulatory strategy, the CTD dossier, EU and US procedures and post-approval activities? Join the 2dayRA training @Zwiers on October 3rd and 4th to get a full overview and obtain ready-to-use knowledge! Interested? Check out https://lnkd.in/eMFPrGkh for the highly interactive F2F program!
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💻 Correct format and content of your regulatory submissions? Let us explain how to use the electronic Common Technical Document to the authorities’ and your convenience. Check out our 2dayRA course on Oct 3rd and 4th at www.az-regulatory.com : a face-to-face training, enabling the combination of highly interactive presentations and “practicing” with typical cases
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