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CLINICAL EVALUATION,

IN VITRO TESTING &


REGULATORY AFFAIRS

COSMETICS
COSMECEUTICALS
MEDICAL DEVICES
BIOCIDES
Borderline claims
Cutting -edge trial equipments
SCIENTIFIC TESTING & SERVICES

USER
TEST & BIOCOMPA ME
CS RY EVA
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QUALATIONS
EFFICAC

ITY &
REGULATORY
AFFAIRS
SENSORY EV

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INSECTS
REPELLEN
USE TES
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PH M I C
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ECOTOXICIT

IC BIODEGRADA BILITY
NT O
AL E FFIC G R ED
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BI
S AC Y ACTIVE IN

Customized R&D projects


New analytical approaches
Experimental tests design
Dinamic & profesional Regulatory Medical specialists approval
Department Multidisciplinary expertise
COSMETICS & COSMECEUTICALS
Complete analytical spectrum

SUNSCREEN
& SOLAR BODY CARE
PROTECTION

MAKE UP FACE CARE

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

MEDICAL DEVICES OPHTHALMIC


DESINFENTANTS INGREDIENTS 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

Microbiological studies (Challenge test)


PROTECTION UVA FP evaluation – PPD (ISO 24442) Non-comedogenicity Ratio UV-A/UV-B. Boots Star rating 2011
Sweat resistance Antioxidant efficacy (ROS, biochemical methods)

Use test / sensory evaluation


Photostability and high photostability evaluation

Open Test Repeated Open Apllication


Patch Test- Single Closed Application

Non-irritating (skin, eyes & mucose)


Tooth whitening Efficacy against biofilm

Skin Absorption / Penetration


Not Phototoxic (OECD 432)
Hypoallergenicity (HRIPT)

Not Citotoxic (ISO 10993)


Effective against tooth sensitivity

Stability studies
ORAL CARE
Efficacy against dental plaque
Efficacy against halitosis

Anti dandruff activity Gloss effect Capillary -fortress (keratin synthesis)


Sebo-regulating effect Color maintenance Hair growth (cell proliferation)
HAIR CARE Anti-hair loss effect Eyelashes strengthener
Hair growth effect

Long lasting make up  Lipstick gloss effect


Coverage effect make up Lipstick long-lasting effect
Matt effect make up Lipstick volume effect
MAKE UP Waterproof eyelash mascara Lipstick non transferable effect
Eyelash mascara volume/Extra-volume effect Lip repair effect
Eyelash mascara lengthening effect Non-comedogenicity
Eyelash mascara curling effect Eyelashes strengthener

HYGIENE &
Tooth whitening (clinical use) Reducing and Anti-Cellulite Effect Maintains Natural flora
PERSONAL Peeling effect (transdermal patches)
CARE

BABIES & KIDS Moisturizing effect Prevention and protection against


Effect on the skin barrier function irritation after diapers use Shooting effect
PRODUCTS

Deodorant Effect
DEODORANTS Antiperspirant effect
No marks on textiles

BORDERLINE Products for atopic skin


COSMETIC Intimate hygiene products
PRODUCTS Products for acne tendency skin
MEDICAL DEVICES

BIOCOMPATIBILITY
MEDICAL DEVICES & BIOCIDES
BIOCIDES

Cytotoxicity Type of products: Healthy skin antiseptics


Instrumental desinfectants
Sensitization
Surface desinfectants
Irritation (skin, eyes, mucose) Insect repellents
Intracutaneous reactivity
Acute Systemic Toxicity (Subacute, Subchronic and Chronic Toxicity)
Type of studies: Efficacy (in suspension and volunteers) of
Genetic Toxicology (in vitro and in vivo) Bactericidal activity
Implantation Easticidal activity
Virucidal activity
Implantation in Combination with Systemic Toxicity
Hemocompatibility Toxicity
Pyrogenicity Skin corrosion (in vitro)
Skin irritation (in vitro – in vivo)
Eye irritation in vitro
Skin sensitization (in vitro – in vivo)
Mutagenicity (Ames Test)
COMPLEMENTARY PRECLINICAL TRIALS
Citogenetic testing in mammalian cells
Gene mutation test in mammalian cells
Stability studies (accelerated, shelf life, in use, etc.) Acute toxicity
Antimicrobial efficacy studies of preservative system Acute oral toxicity
Acute dermal toxicity
Efficacy studies for medical devices desinfectants
Acute inhalation toxicity
Efficacy studies with cell culture Repeated dose toxicity
Bacterial/bacteriostatic activity of surfaces, substances and formulations Subchronic toxicity
Chronic Toxicity

Ecotoxicity & Biodegradability


Fish acute toxicity test
QUALITY CONTROL AND VALIDATION Fish cronic toxicity test
Bioacumulation in fishes
Microbiological control of product (bioburden, sterility, LAL test) Long term toxicity

Microbiological control of processing environment


Physico-chemical properties
Processing water control Identification of substances: spectroscophy
Control of ethylene oxide residues Identification of substances: cromatography
Viscosity
Control of chemical parameters (HPLC, GC-MS, ICP-MS)
Heavy metals
REGULATORY AFFAIRS
COSMETICS & COSMECEUTICALS Coordination and supervision of clinical trials
At Zurko Research, we guide manufacturers of Medical Devices through the entire
The EU Cosmetic Regulation (EC) no. 1223/2009 was adopted in 2009 and entered process, step by step:
into force in July 2013. To fully comply with this obligatory regulation, we support our
clients with:
Application to national competent authority (AEMPS)

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

MEDICAL DEVICES & BIOCIDES


BIOCIDES

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.

We are committed to the five fundamental principles that drive


our business model:

Personalized service and fluent communication with our


clients;
Optimum quality throughout the work process; speed of
response;
Tailor- made solutions for innovative statements and
personalized advice.

We count on experienced renowned professionals, as well as a


wide clinical team of specialists (dermatologists,
ophthalmologists, pediatricians, gynecologists, stomatologists).

ALBACETE - IN VITRO STUDIES


The Quality Department designs and develops all the studies in
accordance with the principles of the Good Clinical Practices
(GCP) and Good Laboratory Practices (GPL).