ServiceUpdated on 13 January 2026
Regulatory service for product registration
About
We provide customized regulatory services covering all activities required to obtain marketing authorization for a wide range of healthcare products, including pharmaceuticals, medical devices, food supplements, cosmetics, and veterinary products.
Our services span the entire regulatory lifecycle, from product classification, regulatory strategy definition, and dossier preparation, to authority interactions, submission management, responses to deficiencies, and post-approval support.
With deep expertise in LATAM regulatory frameworks, we support foreign and local companies in navigating complex requirements efficiently, ensuring compliance, transparency, and timely market access.
Type
- Consulting / Coaching
Applies to
- Biology/Biotechnology
- Pharmaceuticals
- Medicine
- Medical Devices
Organisation
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Daniel Schwarz
Founder, R&D Director, Chief Information Officer at Institute of Biostatistics and Analyses
Brno, Czech Republic
Service
Creation of Tech team/subsidiary in Poland
- Other
- Pharmaceuticals
- Consulting / Coaching
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Wiktor Tarnawski, PhD
CEO at doITinPoland
Warsaw, Poland
Expertise
Simplifying Regulatory Compliance
- Quality Management
Stevie Farkas
Business Development Representative at BrightHills
Salzburg, Austria