Acquired by PLG in October 2022
Zwiers Regulatory Consultancy, being in business for more than a decade, has grown to a large team of experienced and creative regulatory and vigilance professionals. We serve customers in pharma, biotech, and medical device industry smoothening the regulatory pathway to approval and the life cycle when on the market. We cover the full eCTD both content wise as well as on an operational level and provide strategic advice from the very start of development.
From initial clinical study to post-approval compliance
Regulatory Affairs
We ensure your drug is developed up to regulatory standards, your results are presented in a submission ready eCTD dossier, the optimal regulatory prodcedure to approval is followed and authorisation is solidly maintained and extended.
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- RA AZ - Regulatory Affairs from A to Z
From DSUR to Pharmacovigilance Plan
Pharmacovigilance
Safety reporting during clinical trials, risk management, monitoring and signaling, QPPV responsibility: the professionals of Zwiers have the experience and skills to ensure no less than top quality PV.
- GPV compliant procedures and databases
- Expedited and periodic reporting (ASR/DSUR/PSUR)
- QP PV
- Literature searches (detection and reporting)
- Writing, review and assessment (narratives, spontaneous reports, health authority responses)
- Product specific signalling
- Risk management/minimisation
- Educational materials
- Support for post-authorisation safety studies (PASS)
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.
- Notified body interactions
- CE classification
- Competent authorities interactions
- ISO 13485 QMS
- Regulatory strategy plan
- Clinical and biological safety evaluations
- MDR gap analysis
- Risk management plan, analysis and report
- Instructions for Use
- Vigilance and post-market surveillance
- Person Responsible for Regulatory Compliance (PRRC
