Service providers

Zwiers Regulatory Consultancy BV

Solution provided
Technological/Validation solutions, Market solutions
Supplier indentity
General description
Consultancy: providing services on regulatory affairs, pharmacovigilance, medical/technical writing and dossier building (e-CTD) Scope: drugs, medical devices and IVD's (also ISO 13485 certification), borderline products employees > 25 , working as consultants or contractors.
Type of supplier
Service Provider - Professional Advisor /Consultant / Legal / Accounting
Sector of activity:
Business development, Professional Recruitment, Regulatory Requirements, select_or_other, Medical Devices, Orphan Diseases, Pediatrics, Pharmaceutical sector, Specialty Pharmaceuticals
Activity description
Services provided
We help SME's to prepare for the first clinical trials and related activities: protocol, Investigators Brochure. IMPD, IND, scientific advice (EMA, Individual Member States), Orphan Drug Designations, Target Product profile, regulatory strategy. For medical device / IVD companies we support ISO 13485 implementation and certification. We also support Biocompatibility clinical evaluation and other documents supporting the technical file. Meetings with Notified Bodies to discuss the (clinical/ regulatory) strategy.
Terms of availability for SMEs
No
Quality labels and accreditations
No
Contact information
Name
Alex Zwiers
Function
CEO
Phone number
0031 6 104 89 150
Address
KLoosterstraat 9
5349AB Oss
Netherlands

Upcoming events

29
May

This conference aims to address original research in all aspects of radiopharmaceutical science; synthesis, in vitro and ex vivo studies, in vivo biodistribution or imaging, radiopharmacology, radiopharmacy, and translational clinical studies of new targeted radiotracers.

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