weare

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ABOUT US

01.

Azierta is a consultancy firm specialised in Science and Health that is committed to

strengthening the relationship between science and the business environment through the

“Science for Business” concept.

weare

Our mission is to accompany the progress of health industry products in all their cycles: scientific, manufacturing, distribution and

“science for business”. At the same time, we offer infrastructure and health management solutions

that contribute to the improvement of health standards at a global level.

Our vision is to make AZIERTA an international reference in accompanying the health industry, based on a holistic business model founded on a global offer of the highest quality. Developing our activity in a technological environment that allows us to lead a new ecosystem in which the industry finds all the solutions to its needs, while contributing from the knowledge generated to a better modulation and evolution of health management systems and their corresponding health infrastructures.

mission

vision

We provide services in the field of Medicinal Products, Medical Devices, Cosmetics, Food Supplements and Biocides, offering complete solutions throughout

the products’ life cycle, from medical and regulatory support, to toxicology, manufacturing and distribution needs, market access and pharmacovigilance.

Development Registration Manufacturing & distribution

Market access Post-marketing

services

The Azierta project is based on 5 Business Units, offering global and integral solutions thanks to our experience in the field of

science and health.

Business Units

PHARMA HEALTHCARE DIGITAL SCIENCE & GROWTH

HEALTH MANAGEMENT

AUDIT &CERTIFICATION

Our locations

Madrid (HQ)Barcelona

Paris · Milan · Lisbon Bogota Partners

Thanks to our strategic alliances, we combine knowledge and offer specialised consultancy worldwide.

azierta & partners

INDUSTRY

INFOSAÚDE

MERCOSUR

SOLUCIONES GXP

INDUSTRY OF ENGINEERING

CPQ

BUSINESS DEVELOPMENT

KYBORA

PHARMACOVIGILANCE

PVPHARMA

HEALTHCARE

MERCE CAMPS

worldwide

EGYPT & EAST AFRICA

CLAVANETIA

URUGUAY

SOLUCIONES GXP PORTUGAL

INFOSAÚDE

TURKEY

IDE

CENTRAL EUROPE

GMP VERLAG PEITHER AG

MIDDLE EAST

AGON

ourexperience

More than 500 companies from all over the world have given us their trust.

BUSINESS UNITS

02.

PharmaWe provide medical and regulatory support and cater for the needs of toxicology, manufacturing and distribution, market access and pharmacovigilance.

We also provide Transversal Services which support companies in the development of their strategy, market access, training and resource optimization.

We provide personalized technical and scientific support, which ensures legislative compliance and helps companies to improve their daily pharmacovigilance dynamics.

C O M M I T T E D T O P AT I E N T S A F E T Y

Pharmacovigilance

PHARMACOVIGILANCE

Expert Database solutionValidated and 100% operational database in R3

· On-site· Remote

Support in more than 10 European Union countries

· Clinical trials safety· Management of daily PhV· Safety Reports· Liaison with Health Authorities

Expert remote or on-site support tailored to your needs

PSUR, DSUR, RMP, ACO, Signal Detection

VIGILAZIERTA® SAFETY REPORTS AUDIT & GVP COMPLIANCE

LOCAL QPPV & EU-QPPV

PHARMACOVIGILANCE IN CLINICAL TRIALS

PHARMACOVIGILANCE SYSTEM IMPLEMENTATION

PHARMACOVIGILANCE

weareexperts in pharmacovigilance andwe are 100% aligned with the current

European pharmacovigilance environment.

PHARMACOVIGILANCE

PHARMACOVIGILANCE

V A L I D A T E D A N D 1 0 0 % O P E R A T I O N A L D A T A B A S E I N R 3 .

O P T I M I Z E Y O U R D A I L Y W O R K I N P H A R M A C O V I G I L A N C E

Legislative compliance ensured: ICH E2B R3/ ISO ICS.The entire product life cycle in one tool; Clinical Trials and post-marketing.Independent modules as an option.           - R2-R3 migration          - Screening Tool Saves time thanks to the Batch Import system (ZIP with XMLS).PDF/XML Export and XML Import feature. 

Automatic report generation: CIOMS, Cumulative for PSUR. Duplicate search included with an alert in case of possible errors. Integrated MedDRA coding.  Simple, intuitive and easy to use interface.  On-going training and updates at no extra cost.Specialized technical support.Maximum security and total traceability.

G L O B A L E X P E R T S U P P O R T

Regulatory affairs

REGULATORY AFFAIRS

a service adapted to the needs of your company, adapted to the stage of your project.

REGULATORY AFFAIRS

Early stage:Feasibility (Cost/Time) or Regulatory Strategy Report.

Developing stage: Partial or Global Support.

A B

Regulatory strategy Medication registration & maintenance

Auditing & consolidation of registration dossiers Regulatory support through “implants”

Review of promotional material

weoffer

weprovide our extensive experience in all stages of the product life cycle, thus offering regulatory solutions that guarantee the success of your projects.

We are a leading consultant in toxicology, with a specialized area in toxicological support made up of a multidisciplinary team of expert toxicologists accredited by

AETOX, EUROTOX and ERT. 

E X P E R T S I N T O X I C O L O G Y

Toxicology

TOXICOLOGY

+60 countries

Leading consultancy in toxicology

+400 clients trust us

+2800 PDE/ADE reports

Expert scientific team

wedesignpersonalized action plans, following methodologies specifically designed to ensure that the risks are under control and through the various reports to

prove this to the health authorities.

Toxicological evaluation of impurities and risk analysis: Extractable and Leachable, Organic and Mutagenic Impurities, Nitrosamine and Elementals impurities.

Toxicological Reports: PDE, OEL, ERA, Toxicological Expert Reports - ISO10993E-commerce platform.

Global support in health and safety in the workplace: API categorisation and incorporation into multi-product plant, SDS safety sheets.

Support to REACH-CLP & Biocide Regulations.

TOXICOLOGY

We carry out the implementation and maintenance of Quality Systems following the needs of each company to guarantee improvements in the optimum management of

resources and results.

E N S U R I N G C O M P L I A N C E W I T HC O S T - E F F E C T I V E S O L U T I O N S

Quality Systems

QUALITY SYSTEMS

QUALITY SYSTEMS

GMP/GDP certification, GMP Compliance AdviserIn-company training

From botanical support, analysis, health authorizations, facility design to GACP and GMP support.

Audits and/or self-inspections review, development and implementation of documentation. Validations and Quality Risk Management - ICH Q9Implant support

GXP SUPPORT ADVICE AND IMPLEMENTATION OF QUALITY SYSTEMS

MEDICAL CANNABIS CONSULTING

Azierta provides global support in accessing the European Pharma Market for non-European companies.

A C C E S T O E U M A R K E T

Y O U R T U R N K E Y S O L U T I O N T O L A N D I N E U R O P E

Landing in Europe

LANDING IN EUROPE

Become a MAH through a dossier adaptation

Become a suitable CMO for the EU

Become a MAH through dossier acquisition

wemanageprojects on a global scale in terms of territory and services.

How can we help non-EU companies access the EU Pharma market?

“Optimize time and resources to capitalize European business opportunities”

European GMP Certificate

LANDING IN EUROPE

TRAINING

Identify the key points and precisely define the

objectives we aim to achieve through training in order

to provide employees with training that is tailored to the

company.

Theoretical introduction and development of the

syllabus.

Best trainers Guaranteed learningFully suited trainin Update agenda

Conclusions and application of

knowledge.

Knowledge assessment.

wetrainWe offer a tailored in-company training service to train new personnel or to renew and update the knowledge of the staff in any field related to our business units: Toxicology, Quality, Pharmacovigilance,

Regulatory Affairs, Health Products and Cosmetics, Digital Transformation...

WE USE A UNIQUE METHODOLOGY DIVIDED INTO 4 STAGES THAT GUARANTEES PROPER STAFF LEARNING AND THE QUALITY OF THE TRAINING.

ADAPTABILITY QUALITYCOMPETITION PRESENT

O U R M E T H O D O L O G Y

Expert remote or face-to-face support in your department thanks to our network of professionals.

We offer our clients the support of an expert RRAA team.

We assume the objectives of clients like ours.

We have multiple success stories in the implementation ofon site resources and in our facilities.

We offer a flexible solution in terms of time and costs.

Analysis of the client’s needs.

Selection of the most suitable profile.

Choice of work scheme (full-time, part-time, etc).

Start of activity.

Support by Azierta’s team and performance report.Qualified staff from day one.

Optimization of structures and resources.

Improvement of labour management: leaves, staff rotation.

Increase in effectiveness and efficiency.

S U P P O R T T H R O U G H T E C H N I C I A N I M P L A N T S

IMPLANT SUPPORT

methodology01.03.

02.advantages

why azierta?

Thanks to our strategic alliance with Gabinete Técnico Farmacéutico Mercè Camps we work together to consolidate our position as leaders in the Health Consultancy sector in this field, thus unifying the extensive experience of both teams and currently providing services to more than 2,000 clients.

Healthcare It offers global and integrated solutions to companies that develop, research, market, produce or manufacture and distribute Medical Devices, Cosmetics, Food Supplements, Biocides and other products within the HealthCare field.

HEALTHCARE

Market access CE marking, Technical file, Marketing license, Free sale certificate

Quality system

MDSAP

Exports

Post martket follow-up & compliance

Registration of the food business in the General Sanitary Registry (RGS)

Communication of Food Supplements, both at the National and European levelLabeling Review of Food Supplements

Responsible statement 

CPNP notification 

Parapharmacy national codes

Post martket follow-up & compliance

Official Registry of Pesticide Establishments and Services (ROESB) 

Registry of Biocides, at the General Directorate of Public Health (DGSP) 

Disinfectant and Healthy skin antiseptics Registry

MEDICAL DEVICES, IVD & SOFTWARE

FOOD & FOOD SUPPLEMENTS

COSMETICS BIOCIDES

click for + info.

Health ManagementAzierta offers global and integral solutions to companies, from the design and conceptualization of any health model or infrastructure, to the management of both, including consultancy in more specific areas such as: construction, equipment and maintenance.

Digital Science & GrowthDigital Science & Growth (DS&G) is Azierta’s Business Unit dedicated to providing executive advice to clients to contribute to their digital development. This uniquely links digital development and health sciences by responding to the growing market demand to sustainably drive business results. DS&G’s approach also brings value to companies in any industry where health considerations are part of the business model equation.

DS&G offers various digital services to contribute to the business’ aspirations in any of the commercial, operational, research and development and manufacturing areas. We conceive the digital approach as a commitment to modernization, automation and information management for better decision-making.

DIGITAL BUSINESS

DIGITAL EXPERIENCES DATA & ANALYTICS

DIGITAL CAPABILITIES

CUSTOMER ENGAGEMENT

We created a digital transformation office integrated into the client’s organization as a method to accelerate the company’s profitable growth, productivity, and profitability, digitally transforming the business model and operations.

We are a Digital Factory of operational solutions with a technological base and integration of channels. We help our customers to choose, adapt and implement technological solutions by integrating partners in creativity, content, publishing, and digital services. We provide end-to-end turnkey solutions.

We are experts in creating experiences in health agents, patients, and health consumers, using all the media and multi-channel communication platforms. We build spaces for collaboration and interaction increasing the trust and relationship with companies, their brands, and services in the health ecosystem. Online educational services Virtual Congresses of digital promotion Interactive services - eDetailing and Remote Selling.

We are specialists in the creation and use of data as an essential unit of the base information for the best business decisions. We create and maintain data warehouses and apply descriptive, prospective, and predictive techniques and customer knowledge.

We are experts in Inbound Marketing, applying methodologies and solutions that ease connectivity, customer confidence and adoption of messages and proposals linking health professionals and patients among themselves and with the organization.

DIGITAL BUSINESS DIGITAL CAPABILITIES DIGITAL EXPERIENCES DATA & ANALYTICS

CUSTOMER ENGAGEMENT

DIGITAL SCIENCE & GROWTH

Audit & CertificationAzierta offers global and integral solutions to companies that need auditing processes in the environment of pharmacovigilance, regulatory affairs, in the field of GCP (Good Clinical Practice), GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), GPP (Good publication practice) and in the environment of any certification or accreditation required for the services and products in their core areas. This guarantees the overall quality of these services and products.

thankyouGlobal Science and Health Consultancy FirmServices in Science, Industrial, Digital Transformation and Health Management

azierta.com