Zeincro provides outstanding regulatory affairs services including pricing and reimbursement services to our clients in Greece, Turkey and Cyprus.

Zeincro is a member of the global regulatory intelligence database(IDRAC), and PharmaPrice International (), specialists in pricing, reimbursement and market access.

The regulatory team is comprised of regulatory experts experienced in all regulatory issues.

More than 40 clients, local and multinational pharmaceutical companies plus Pharmaceutical Regulatory European consultants have used Zeincro's regulatory services.

For each project a project team is assigned. The project team is comprised of a Regulatory Affairs Manager, a Regulatory Affairs Officer(s) and the Medical Advisor, M.D.. The project's metrics are controlled from the Planning and Controlling Manager. This project team guarantees high quality deliverables based on good planning, responsible coaching, efficient management and continuous quality controlling adherence to timelines and recruitment goals.

Zeincro as a member of PharmaPrice International is able to support the development of market access strategies as well as their ultimate implementation. This is accomplished through our intimate understanding of P&R, country healthcare systems and familiarity with payers, physicians, pharmacists and other key stakeholders. Zeincro and PharmaPrice provide support on respective pricing and funding decisions to be taken.

On-Site placement

Zeincro can provide on-site placement of regulatory staff according to the client's needs. This way the client may use the services of qualified personnel on a flexible basis, in order to relieve workload or fill vacancies left by long-term absence of the permanent staff.

Marketing Authorizations

Zeincro ensures efficient submissions and follow-up activities both for National Authorizations and Community Authorizations:

National Authorizations:

• Through regular communication with National Regulatory Authorities (NRA) and constant review of the legislation, Zeincro ensures quality in the following activities for National Marketing Authorizations:
• Preparation and submission of registration dossiers to NRA
• Follow-up of the application and support on any questions or requirements from NRA
• Variations of Marketing Authorizations
• Renewals of Marketing Authorizations

Community Authorizations:

• The Marketing Authorizations issued by the European Commission are valid throughout the EU. Through its office in the UK, Zeincro undertakes the preparation and submission of the registration dossier to EMEA (centralized procedure)

Pricing / Reimbursement

Zeincro offers services in preparation and submission of the price and/or reimbursement application dossier to the National Authorities, according to the national regulations. Follow-up activities and support on any questions or requirements from the National Authorities are dealt promptly and efficiently, in close collaboration with the client.

Translations

Zeincro undertakes translations of documents that need to be submitted in the national language during registration procedures such as: Summaries of Product Characteristics and Patient Information Leaflets. Translation of other documents of administrative, pharmaceutical, chemical, medical or other relevant context, are also undertaken to meet the client 's needs.