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Medical Cannabis Consulting
Experts in management and assessment of the production of medicinal cannabis.
The regulation of the cultivation and production of cannabis derivatives favours the emergence of a new industry with a large global market .It is estimated that the market for medicinal cannabis could reach 50 billion euros by 2025.
From Azierta we offer an expert support to support our clients in the introduction of products derived from cannabis to this emerging industry.
Our projects cover all customer needs:
- Botanical support
- Health Authorisations
- Design of installations
- Implementation and certification of quality systems: GACP and GMP
2018On CPhI since
2018On CPhI since
More Products from AZIERTA
Azierta provides global support in accesing to European Market to Non-European companies
European Pharma market access support services: There are three main strategies that may be implemented on an individual basis, or alongside each other, depending on your company needs, in order to secure your correct positioning in the EU Market.
- Become a Suitable CMO for Europe
- Become a MAH through Dossier Adaptation
- Become a MAH through a Dossier Acquisition
- CE Marking and Technical File
- Importer and Authorised Representative in the EU
- Market Register Communication
For further information, please visit: https://www.azierta.com/en/pharma/services/internationalization
At Azierta, we implement and maintain Quality Systems according to the needs of each company for enhanced resource management and results.
- In-company traininig
- GxP Support: GMP/GDP Certification and GMP Compliance Adviser
- Assessment and implementation of Quality Systems: Audits and/or self-inspections, Review development and implementation of SOPs, Validations, Quality Risk Managemen-ICH Q9
- Implants Support
- Medical Cannabis Consulting
"We are experts in Quality Management with vast experience in the pharmaceutical industry"
For more information please visit: https://www.azierta.com/en/pharma/quality-systems
Azierta provides executive advice to clients for winning go-to-customer approaches and next-generation operating models with digital embedded.The solutions we offer are:
- Digital Business:Accelerate profitable growth by digitally transforming the business model and operations.
- Customer Engagement:Native digital experts in inbound marketing for healthcare professionals and patients.
- Digital Experiences:Experts in creating multi-channel and multi-audience experiences in health ecosystems.
- Data & Analytics:Digital Data & Analytics professionals in the healthcare and pharmaceutical value chain.
- Digital Capabilities:Digital Factory integrating partners in creativity, content, publishing and digital services.
Highly specialised technical advice and support compliance with Regulation (EU) 1907/2006 (REACH) as well as Regulation (EU) 1272/2008 (CLP) according to the corresponding guides published by ECHA.
Protection of human health and the environment from the risks that can arise from the manufacture, marketingand use of chemical substances and mixtures.
More than 10 years of experience.
For further information visit www.azierta.com/pharma/toxicology/clp-reach-regulation
We offer a service adapted to the needs of your company, working from the initial stage of registration to day-to-day regulatory activities, providing our experience in different areas, and thus offering global regulatory solutions and external support if required.
- Regulatory Strategy
- Regulatory Intelligence
- Preparation, presentation and follow-up of the registration dossier until the marketing authorisation of a medicine is obtained.
- Regulatory support in all local activities necessary for the marketing or maintenance of the medicines.
- We adapt the required common eCTD format by requesting the necessary information.
- Review of promotional materials for medicines, selecting the appropriate texts to achieve the marketing objectives.
Innovation in the management of relations with our clients, with a 360 vision of Science and Health environment, applied to Business.
Aligned to our clients objetive to present and market their product, so that reaches the citizen and/or patient adequately. Whether it is a medicine, a health product, a biological product, a biocide, a food supplement or a cosmetic, they all have three processes in common:
- The technical-scientific process/circle before, during and after the launch.
- The manufacturing process/circle once the product is on the market.
- The process/circle that gives scientific added value, within the reference market after the launch.
At Azierta, we have an area specialized in toxicological support composed of a multidisciplinary team of expert toxicologists accredited by AETOX, EUROTOX and ERT.
Identification and analysis of impurities to assess the risk it may pose for human health:
- Extractable and Leachable
- Organic and Mutagenic (in accordance to established guidelines ICH Q3A/Q3B & ICH M7)
- Nitrosamine Impurities
- Elemental impurities ( ICH Q3D)
For further information, please visit: https://www.azierta.com/en/pharma/toxicology
At Azierta, we have an area specialized in toxicological support composed of a multidisciplinary team of expert toxicologists accredited by AETOX, EUROTOX and ERT. We design personalized action plans following specific methodologies to ensure that risks are undercontrol and through the reports evidence it to Health Authorities.
- PDE/ADE reports: Development of PDE/ADE (Permited Daily Exposure for any API according to EMA regulations(EMA/CHMP/CVMP/SWP/169430/2012) for the pharmaceutical and veterinary industry.
- OEL reports: Calculation an upper limit in workplace air must be established for any API present.
- Toxicological Expert reports: Biological Evaluation of Medical Devices designed to meet ISO 10993-1:2018
- ERA reports: Development of ERA reports for the assessment and analysis of an API’s effects on the environment.
Is your safety database adapted to R3?
VIGILAZIERTA is a database with extensive experience that has proven to be a cost-effective and customizable technological solution capable of optimizing daily work in Pharmacovigilance.
- Created by and for experts
- Ensure compliance
- Cost-Effective Solution
- Easy to use
For more information please visit: https://www.azierta.com/en/pharma/pharmacovigilance/vigilazierta
Azierta and CPQ ingenieros have decided to sign a strategic alliance in order to combine the experience and knowledge of both firms. In this way, they will have a joint offer at a consultancy level for the design of installations in pharmaceutical plants.
News AZIERTA CONSULTANCY and GTF MERCÉ CAMPS sign a strategic alliance in the area of Medical DevidesThe Alliance will jointly design and market products and services related to medical devices, cosmetics and food supplementsThe Alliance will be a leader in the Healthcare Consulting sector in this area.
We offer a service adapted to the needs of your company,providing our experience in different areas, and thus offering global regulatory solutions and external support if required.
We are focused on result meeting our clients’ needs with quality, commitment, reliability and flexibility
We design innovative and personalized cost-effective solutions to help our clients to adapt to the new PV enviromnment
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