COSMETICS & COSMECEUTICALS The EU Cosmetic Regulation (EC) no. 1223/2009 was adopted in 2009 and entered into force in July 2013. To fully comply with this obligatory regulation, we support our clients with: Preparation and revision of the Product Information File (PIF) Revision and translation of labelling Review and integration of the technical and administrative documentarion provided by the company. Elaboraton of the Material Safety Data Sheets (MSDS). Preparation ans signature of the safety assessment of cosmetic products. Entering data into the European Cosmetic Products Notification Portal (CPNP).
 
 MEDICAL DEVICES At Zurko Research we offer our clients all the necessary support for their medical devices, from all risk clases (I, II, III): CE Marking We celebrate the complete Technical File and Risk Management documentation. Licenses We elaborate and manage all type of documentation and procedure for medical devices Activity License obtainment. ISO 13485 We support our client in the establishment and review of the Quality Management System required for medical devices.
Coordination and supervision of clinical trials. Application to national competent authority (AEMPS) Application to the Clinical Research Ethics Committee (CREC) Identification of the Research Centre (public or private) Coordination of multi-centre research Support with the drawing up of the clinical research Plan (PIC) Presentation and defense of the project before the CREC Support with the selection of patients panel Trial supervision Assistance with the drafting of the final report


 



BIOCIDES Biocidal products are subject to different regulations depending on the intended purpose indicated in the labeling and instructions for use of the products. In addition to conducting the necessary tests, Zurko is responsible for the preparation of all regulatory procedures for the commercialization of: - Antiseptics for healthy skin, including those for pre-operative surgical area. - Desinfectants for environment and surface used in medical ans surgical areas, not in direct contact with the patient.
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Objective:
In vivo assessment of the antiplaque effectiveness of a new mouthwash formula.
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  • LATEST NEWS
    Cosmetorium 2016 was a great success for Zurko Research, which we expect to repeat in 2017.
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COSMETICS & COSMECEUTICALS The EU Cosmetic Regulation (EC) no. 1223/2009 was adopted in 2009 and entered into force in July 2013. To fully comply with this obligatory regulation, we support our clients with: Preparation and revision of the Product Information File (PIF) Revision and translation of labelling Review and integration of the technical and administrative documentarion provided by the company. Elaboraton of the Material Safety Data Sheets (MSDS). Preparation ans signature of the safety assessment of cosmetic products. Entering data into the European Cosmetic Products Notification Portal (CPNP).
 
 MEDICAL DEVICES At Zurko Research we offer our clients all the necessary support for their medical devices, from all risk clases (I, II, III): CE Marking We celebrate the complete Technical File and Risk Management documentation. Licenses We elaborate and manage all type of documentation and procedure for medical devices Activity License obtainment. ISO 13485 We support our client in the establishment and review of the Quality Management System required for medical devices.
Coordination and supervision of clinical trials. Application to national competent authority (AEMPS) Application to the Clinical Research Ethics Committee (CREC) Identification of the Research Centre (public or private) Coordination of multi-centre research Support with the drawing up of the clinical research Plan (PIC) Presentation and defense of the project before the CREC Support with the selection of patients panel Trial supervision Assistance with the drafting of the final report


 



BIOCIDES Biocidal products are subject to different regulations depending on the intended purpose indicated in the labeling and instructions for use of the products. In addition to conducting the necessary tests, Zurko is responsible for the preparation of all regulatory procedures for the commercialization of: - Antiseptics for healthy skin, including those for pre-operative surgical area. - Desinfectants for environment and surface used in medical ans surgical areas, not in direct contact with the patient.
  • DENTAL CLINICAL TRIAL

Objective:
In vivo assessment of the antiplaque effectiveness of a new mouthwash formula.
  • Cosmetorium 2016 was a great success for Zurko Research, which we expect to repeat in 2017.
COSMETICS & COSMECEUTICALS The EU Cosmetic Regulation (EC) no. 1223/2009 was adopted in 2009 and entered into force in July 2013. To fully comply with this obligatory regulation, we support our clients with: Preparation and revision of the Product Information File (PIF) Revision and translation of labelling Review and integration of the technical and administrative documentarion provided by the company. Elaboraton of the Material Safety Data Sheets (MSDS). Preparation ans signature of the safety assessment of cosmetic products. Entering data into the European Cosmetic Products Notification Portal (CPNP).
 
 MEDICAL DEVICES At Zurko Research we offer our clients all the necessary support for their medical devices, from all risk clases (I, II, III): CE Marking We celebrate the complete Technical File and Risk Management documentation. Licenses We elaborate and manage all type of documentation and procedure for medical devices Activity License obtainment. ISO 13485 We support our client in the establishment and review of the Quality Management System required for medical devices.
Coordination and supervision of clinical trials. Application to national competent authority (AEMPS) Application to the Clinical Research Ethics Committee (CREC) Identification of the Research Centre (public or private) Coordination of multi-centre research Support with the drawing up of the clinical research Plan (PIC) Presentation and defense of the project before the CREC Support with the selection of patients panel Trial supervision Assistance with the drafting of the final report


 



BIOCIDES Biocidal products are subject to different regulations depending on the intended purpose indicated in the labeling and instructions for use of the products. In addition to conducting the necessary tests, Zurko is responsible for the preparation of all regulatory procedures for the commercialization of: - Antiseptics for healthy skin, including those for pre-operative surgical area. - Desinfectants for environment and surface used in medical ans surgical areas, not in direct contact with the patient.
  • DENTAL CLINICAL TRIAL

Objective:
In vivo assessment of the antiplaque effectiveness of a new mouthwash formula.
  • Cosmetorium 2016 was a great success for Zurko Research, which we expect to repeat in 2017.
COSMETICS & COSMECEUTICALS The EU Cosmetic Regulation (EC) no. 1223/2009 was adopted in 2009 and entered into force in July 2013. To fully comply with this obligatory regulation, we support our clients with: Preparation and revision of the Product Information File (PIF) Revision and translation of labelling Review and integration of the technical and administrative documentarion provided by the company. Elaboraton of the Material Safety Data Sheets (MSDS). Preparation ans signature of the safety assessment of cosmetic products. Entering data into the European Cosmetic Products Notification Portal (CPNP).
 
 MEDICAL DEVICES At Zurko Research we offer our clients all the necessary support for their medical devices, from all risk clases (I, II, III): CE Marking We celebrate the complete Technical File and Risk Management documentation. Licenses We elaborate and manage all type of documentation and procedure for medical devices Activity License obtainment. ISO 13485 We support our client in the establishment and review of the Quality Management System required for medical devices.
Coordination and supervision of clinical trials. Application to national competent authority (AEMPS) Application to the Clinical Research Ethics Committee (CREC) Identification of the Research Centre (public or private) Coordination of multi-centre research Support with the drawing up of the clinical research Plan (PIC) Presentation and defense of the project before the CREC Support with the selection of patients panel Trial supervision Assistance with the drafting of the final report


 



BIOCIDES Biocidal products are subject to different regulations depending on the intended purpose indicated in the labeling and instructions for use of the products. In addition to conducting the necessary tests, Zurko is responsible for the preparation of all regulatory procedures for the commercialization of: - Antiseptics for healthy skin, including those for pre-operative surgical area. - Desinfectants for environment and surface used in medical ans surgical areas, not in direct contact with the patient.
 
COSMETICS & COSMECEUTICALS The EU Cosmetic Regulation (EC) no. 1223/2009 was adopted in 2009 and entered into force in July 2013. To fully comply with this obligatory regulation, we support our clients with: Preparation and revision of the Product Information File (PIF) Revision and translation of labelling Review and integration of the technical and administrative documentarion provided by the company. Elaboraton of the Material Safety Data Sheets (MSDS). Preparation ans signature of the safety assessment of cosmetic products. Entering data into the European Cosmetic Products Notification Portal (CPNP).
 
 MEDICAL DEVICES At Zurko Research we offer our clients all the necessary support for their medical devices, from all risk clases (I, II, III): CE Marking We celebrate the complete Technical File and Risk Management documentation. Licenses We elaborate and manage all type of documentation and procedure for medical devices Activity License obtainment. ISO 13485 We support our client in the establishment and review of the Quality Management System required for medical devices.
Coordination and supervision of clinical trials. Application to national competent authority (AEMPS) Application to the Clinical Research Ethics Committee (CREC) Identification of the Research Centre (public or private) Coordination of multi-centre research Support with the drawing up of the clinical research Plan (PIC) Presentation and defense of the project before the CREC Support with the selection of patients panel Trial supervision Assistance with the drafting of the final report


 



BIOCIDES Biocidal products are subject to different regulations depending on the intended purpose indicated in the labeling and instructions for use of the products. In addition to conducting the necessary tests, Zurko is responsible for the preparation of all regulatory procedures for the commercialization of: - Antiseptics for healthy skin, including those for pre-operative surgical area. - Desinfectants for environment and surface used in medical ans surgical areas, not in direct contact with the patient.
COSMETICS & COSMECEUTICALS The EU Cosmetic Regulation (EC) no. 1223/2009 was adopted in 2009 and entered into force in July 2013. To fully comply with this obligatory regulation, we support our clients with: Preparation and revision of the Product Information File (PIF) Revision and translation of labelling Review and integration of the technical and administrative documentarion provided by the company. Elaboraton of the Material Safety Data Sheets (MSDS). Preparation ans signature of the safety assessment of cosmetic products. Entering data into the European Cosmetic Products Notification Portal (CPNP).
 
 MEDICAL DEVICES At Zurko Research we offer our clients all the necessary support for their medical devices, from all risk clases (I, II, III): CE Marking We celebrate the complete Technical File and Risk Management documentation. Licenses We elaborate and manage all type of documentation and procedure for medical devices Activity License obtainment. ISO 13485 We support our client in the establishment and review of the Quality Management System required for medical devices.
Coordination and supervision of clinical trials. Application to national competent authority (AEMPS) Application to the Clinical Research Ethics Committee (CREC) Identification of the Research Centre (public or private) Coordination of multi-centre research Support with the drawing up of the clinical research Plan (PIC) Presentation and defense of the project before the CREC Support with the selection of patients panel Trial supervision Assistance with the drafting of the final report


 



BIOCIDES Biocidal products are subject to different regulations depending on the intended purpose indicated in the labeling and instructions for use of the products. In addition to conducting the necessary tests, Zurko is responsible for the preparation of all regulatory procedures for the commercialization of: - Antiseptics for healthy skin, including those for pre-operative surgical area. - Desinfectants for environment and surface used in medical ans surgical areas, not in direct contact with the patient.