ZEMIR PHARMA CONSULTING
Portuguese regulatory and technical consulting firm founded in 2002 that provides pharmacovigilance, regulatory affairs, market access, quality management and compliance services to pharmaceutical, medical device, cosmetic and supplement stakeholders. The company reports ISO 9001:2015 certification (2021) and offers training and specialized operational support from its office in Prior Velho, Portugal.
Industries
Nr. of Employees
small (1-50)
ZEMIR PHARMA CONSULTING
Portugal, Cagayan, Philippines, Asia
Services
Safety monitoring, signal detection, case processing, pharmacovigilance documentation and regulatory reporting support including QPPV functions.
Preparation and submission of regulatory dossiers, labeling and product information, notifications and registry entries at EU and national level.
Advisory on pricing strategies, price review filings and management of processes with pricing authorities.
Implementation and review of quality management systems, supplier evaluation, preparation of documentation for GMP/GDP licensing and compliance activities.
Support for classification, technical documentation (MDR Annex II), CE marking processes, EUDAMED registration, vigilance and QMS support for devices.
Regulatory evaluation, safety reporting, dossier preparation, labeling review and portal notifications for cosmetics and food supplements.
Safety monitoring, signal detection, case processing, pharmacovigilance documentation and regulatory reporting support including QPPV functions.
Preparation and submission of regulatory dossiers, labeling and product information, notifications and registry entries at EU and national level.
Advisory on pricing strategies, price review filings and management of processes with pricing authorities.
Implementation and review of quality management systems, supplier evaluation, preparation of documentation for GMP/GDP licensing and compliance activities.
Support for classification, technical documentation (MDR Annex II), CE marking processes, EUDAMED registration, vigilance and QMS support for devices.
Regulatory evaluation, safety reporting, dossier preparation, labeling review and portal notifications for cosmetics and food supplements.
Expertise Areas
- Pharmacovigilance and signal management
- Regulatory affairs for medicines, devices, cosmetics and supplements
- Medical device technical documentation and conformity assessment
- Market access and pricing
Key Technologies
- EudraVigilance data analysis (EVDAS)
- Pharmacovigilance System Master File (PSMF) processes
- Risk Management Plan (RMP) lifecycle management
- Legibility testing and bridging methodologies
News & Updates
Reported attainment of ISO 9001:2015 certification, awarded in 2021 and certified by SGS.
Reported attainment of ISO 9001:2015 certification, awarded in 2021 and certified by SGS.