Loading...
 

Quality Assurance Services

Zeincro’s QA department comprises of professionals with high education and experience on GxP regulated activities and quality assurance concept.  Zeincro’s QA department provides QA services to local and multinational pharmaceutical companies, medical devices companies, global CROs and medical associations.

Flexibility, experience in multidisciplinary projects and deep knowledge of applicable legislation are the major strengths of our department.

 

The Quality Assurance department of Zeincro provides a wide range of services:

 

Quality Assurance activities

  • Writing/ review/ update of SOPs on GxP regulated activities
  • Gap analysis on SOPs and QA system
  • Risk assessment and risk management
  • Assistance for certification for ISO 9001:2015
  • Assistance for certification for GDP requirements for medical devices
  • Training of personnel on GxP
  • Conduct of internal audits
  • Evaluation of external vendors
  • Conduct of vendors’ audits
  • Consultation and follow-up of CAPAs
  • Local and EU legislation monitoring and guidelines’ update regarding implementation of GxP requirements

 

Quality assurance activities for MAH

  • Acting as local QA/QP for pharmaceutical products
  • Local adaptation of global SOPs and policies
  • Assessment and evaluation of subcontractors/ service providers
  • Audits and assessment of distribution centers
  • Management of product quality complaints (PQCs)
  • Assistance in case of recalls
  • Management of deviations/non-compliances
  • Root cause analysis and CAPA plan
  • Conduct of self-inspections
  • Training of staff on applicable GxP guidelines and legislation

 

Quality assurance activities for clinical trials

  • Training of Investigators and site staff on GCP (mutually recognized by TransCelerate Biopharma Inc.)
  • Training of site Coordinators
  • Conduct of clinical site audits and pre-inspections
  • Conduct and evaluation of central and/or local laboratories
  • Set-up of units for Phase I, BE/BA studies

ABOUT US

ZEINCRO is a leading contract research organization covering more than 21 countries in Europe, with a special focus in the region of Central and South Eastern Europe (Albania, Austria, Bulgaria, Cyprus, Czech Republic, Germany, Estonia, FYROM, Greece, Hungary, Latvia, Lithuania, Malta, Moldova, the Netherlands, Poland, Romania, Slovakia, Switzerland, Turkey and Ukraine).

Read more

CONTACT US

  • Email:  info@zeincro.com

ZEINCRO : member of

European CRO Federation (EUCROF)

© 2012-2020 ZEINCRO Group - All rights reserved.
Developed by LogicONE