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Regulatory Affairs Services

ZEINCRO’s regulatory team is comprised of experts experienced in all regulatory issues. We provide a wide range of regulatory affairs services, including pricing and reimbursement, to our clients. We focus on the client’s needs and requirements, to provide services of high quality that meet their expectations.

 

Flexibility, experience in multidisciplinary projects, excellent relations with Health Authorities and deep knowledge of legislation and regulatory environment are the major strengths of our department.

 

The regulatory affairs department of ZEINCRO offers a wide range of services to its clients summarized below:

  • Registration of pharmaceutical products through National, Mutual Recognition and Decentralised procedures.
  • Maintenance of the Marketing Authorisations through variations and renewals.
  • Preparation and submission of Pricing and Reimbursement applications.
  • Control of packaging and promotional material and other marketing related services.
  • On-site placement of regulatory staff according to the client’s needs.
  • Effective deals with the authorities and intensive follow-up in every submission, in order to ensure timely conclusion of the national phase of the procedures.
  • High quality translations of the Summaries of Product Characteristics, Labeling and Patient Leaflet to the local language.
  • Consultancy services concerning the local regulatory provisions and requirements.
  • Consultancy services for medical devices, cosmetics, food supplements, biocides.
  • Training in Regulatory Affairs.

 

 

Pharmacovigilance & Medical Devices Vigilance Services

The business of pharmacovigilance/drug safety and product safety in general (medical device vigilance, veterinary pharmacovigilance, cosmetovigilance) is a business more based on trust between client and vendor than any other business. This is why quality is the main focus of our pharmacovigilance and product safety services. We are proud of our client centric company culture highly sensitive to individual needs. We know that no two clients are alike and our philosophy is to shape our support in the form of the best symbiosis with your needs and structure. We are offering cost-effective solutions for global pre- and post-approval pharmacovigilance as well as related services in product safety; but what distinguishes us most, are our deep roots on local level in multiple countries.  


During the eleven years of our product safety operations we have grown pharmacovigilance teams with targeted expertise to achieve stability and have combined it with lean management, short timelines of implementation of projects, and efficient pathways of communication.  Based on experience we have implemented a specialized recruitment approach to attract the right talent for the right pharmacovigilance tasks globally and regionally. Our strength is in our people who posses strong academic background (pharmacists, medical doctors and life-science graduates), deep knowledge of legislation and broad industry experience. Year after year high retention rates secure continuity and are basis for expansion.


We add not only value to your system but build and sustain your image and reputation.

 

We offer a complete range of Pharmacovigilance/Drug Safety and Product Safety services, including:

  • Set up and implementation of Pharmacovigilance System, including writing/review of SOPs and preparation/maintenance of Pharmacovigilance System Master File (PSMF).
  • Collection, Assessment and Reporting of Adverse Events (AEs) originating from clinical trials or other organised data collection systems, spontaneous reports or literature.
  • Investigation and Assessment of Incidents and Near-Incidents.
  • International Literature Review and Local Literature review.
  • Provision of Qualified Person for Pharmacovigilance (QPPV) in Europe.
  • Provision of Local contact person for Pharmacovigilance/ Local QPPV in multiple countries.
  • Medical evaluation of Pharmacovigilance data and Signal Detection in order to carry out the Risk – Benefit assessment.
  • Writing and Submission to the Health Authorities of Clinical Safety Reports (such as Development Safety Update Reports (DSURs)) and Periodic Safety Update Reports (PSURs).
  • Operation of Risk Management System (RMS), including the writing of Risk Management Plan (RMP) and the preparation of material for Risk Minimisation Activities.
  • Audits on Pharmacovigilance and consulting Health Authority Inspections.
  • Registration to EudraVigilance and registration of products to XEVMPD.
  • Safety Data Exchange Agreements (SDEA) preparation/review and maintenance
  • Training in Pharmacovigilance

 

Interest Form

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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).

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CONTACT US

  • Email:  info@zeincro.com

ZEINCRO : member of

European CRO Federation (EUCROF)

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