Академический Документы
Профессиональный Документы
Культура Документы
COSMETICS
COSMECEUTICALS
MEDICAL DEVICES
BIOCIDES
Borderline claims
Cutting -edge trial equipments
SCIENTIFIC TESTING & SERVICES
USER
TEST & BIOCOMPA ME
CS RY EVA
LUATION TIBIL
ITY OTH DI
TI SEN
SO ER
P
STU RE-C
CA
E R&
D DIE LIN
S ICA
SM
LD
L
CO
EV
CL
IN
ICE
Y
ICA
T
FE
LT
S
SA
RIA
LS
VALID
Y
QUALATIONS
EFFICAC
ITY &
REGULATORY
AFFAIRS
SENSORY EV
T
INSECTS
REPELLEN
USE TES
ALUA
T&
S
ENT
Y
T
CE
TAN
& IN SURFA
C
DE TRUM
TION
FEC
ICA
S
SIN
EFF
AN &
C
FE EPTI
T
SIN TIS
CT
R&
DE AN
CO
IN
SK
D
-
ICO A L
SM
YS
PH M I C
E
SA CH
ES
ES
I
EC
UT UD
Y
ICIT
FE TOX
ID
TY T
C
Y&
E
SS
ECOTOXICIT
IC BIODEGRADA BILITY
NT O
AL E FFIC G R ED
IE
BI
S AC Y ACTIVE IN
SUNSCREEN
& SOLAR BODY CARE
PROTECTION
HYGIENE &
PERSONAL CARE INGREDIENTS ORAL CARE
BORDER LINE
COSMETIC HAIR CARE
PRODUCTS
BABIES &
KIDS
DEODORANTS
PRODUCTS
Wide range of volunteers panels:
Support for the full compliance with Ratial specificity
European Regulation 1223/2009 From 3-month to 3-year babies
From raw material to final product All type of dermatological characteristics
Viability studies for CE mark Pre-clinical studies
achievement Coordination and supervision
Literature-based clinical investigation of clinical investigation
MEDICAL DEVICES & BIOCIDES
SKIN ANTISEPTICS
& DERMATOLOGICAL
DESINFECTANTS PRODUCTS
MEDICAL-SURGICAL GYNECOLOGICALS
DESINFECTANTS PRODUCTS
IMPLANTABLE,
MONOUSE & DENTAL & ORAL
REUSABLE PRODUCTS
PRODUCTS
INJECTION, PERSONAL
INFUSION & HYGIENE
TRANSFUSION PRODUCTS
PRODUCTS
Collaboration with
Cross-sectors expertise for borderline
EU Research
products (cosmetics, medical devices,
Centers and Universities.
biocides & pharma)
IN VIVO EFFICACY IN VITRO EFFICACY IN VIVO IN VITRO
SAFETY SAFETY
COSMETICS & COSMECEUTICALS
Moisturizing effect (hydration kinetics) Sebo-regulating effect Antioxidant efficacy (ROS, biochemical methods)
Anti-wrinkles Matifying effect Anti-wrinkles
Anti-aging effect Astringent effect Anti-ageing
FACE CARE Firming and elasticity effect Comedolitic effect Whitening effect
Tensor / lifting effect Whitening effect Suncreen effect after solar radiation
Efffect on the skin barrier function Depigmenting effect Photoaging efficacy after solar radiation
Peeling/Exfoliating effect Non-comedogenicity
Regenerating effect
Moisturizing effect (hydration kinetics) Anti-stretchmarks effectiveness Antioxidant efficacy (ROS, biochemical methods)
Firming and elasticity effect Depilatory effectiveness Collagen and elastin synthesis stimulation
BODY CARE Anti-Cellulitis Effect Tanning accelerating effect Inhibition of collagenase and elastase
Reducing Effect Tanning effect maintenance
Sun Protection Factor SPF (ISO 24444; FDA) Low adherence to the sand UVA PF evaluation (ISO 24443; Colipa 2011)
SUNSCREEN Water Resitance Tanning booster Critical wavelength evaluation
& SOLAR Very Water Resistance (Colipa 2005) Efficacy against redness after solar radiation Water and very Water Resistance
Stability studies
ORAL CARE
Efficacy against dental plaque
Efficacy against halitosis
HYGIENE &
Tooth whitening (clinical use) Reducing and Anti-Cellulite Effect Maintains Natural flora
PERSONAL Peeling effect (transdermal patches)
CARE
Deodorant Effect
DEODORANTS Antiperspirant effect
No marks on textiles
BIOCOMPATIBILITY
MEDICAL DEVICES & BIOCIDES
BIOCIDES
Preparation or revision of the Product Information File (PIF) Application to the Clinical Research Ethics Committee (CREC)
Revision and translation of labelling Identification of the Research Centre (public or private)
Review and integration of the technical and administrative documentation provided by Coordination of multi-centre research
the company Support with the drawing up of the clinical research Plan (PIC)
Elaboration of the Material Safety Data Sheets (MSDS) Presentation and defense of the project before the CREC
Preparation and signature of the safety assessment of cosmetic products Support with the selection of patients panel
Entering data into the European Cosmetic Products Notification Portal (CPNP) Trial supervision
Assistance with the drafting of the final report
At Zurko Research we offer our clients all the necessary support for their medical Biocidal products are subject to different regulations depending on the intended
devices, from all risk clases (I, IIa, IIb, III): purpose indicated in the labeling and instructions for use of the products.
CE Marking
we elaborate the complete Technical File and Risk Management documentation. In addition to conducting the necessary tests, Zurko is responsible for the preparation
of all regulatory procedures for the commercialization of:
Licences
We elaborate and manage all type of documentation and procedure for medical
device Activity License obtainment. Antiseptics for healthy skin, including those for pre-operative surgical area
Desinfectants for environment and surface used in medical and surgical areas,
ISO 13485
We support our client in the establishement and review of the Quality Management not in direct contact with the patient.
System required for medical devices.
FACILITIES
WHO WE ARE
ZURKO RESEARCH, created in 2005, is a centre for clinical and
MADRID - CLINICAL TRIALS
in vitro evaluation, testing the safety and efficacy of cosmetic
and cosmeceutical products, as well as medical devices.