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Services for Biopharmaceuticals and Startups
Discover everything Konexio Biotech can do for your pharmaceutical lab.
- Design and renovate your facilities and equip them.
- Design and execute your preclinical and clinical trials required for your product according to the applicable regulations.
- Design and develop the regulatory strategy your product requires.
- Train your scientific staff in pharmaceutical regulations (GxP training).
- Facilitate your product's market access.
- Seek external funding.
- Validate your analytical methods and support your process validations and qualification of equipment and facilities.
- Perform audits of medical information for your promotional material.
Sectors in which we operate
Pharmaceutical Laboratories
- Design the biotechnological product that best fits your business plan.
- Renovate your facility and select the necessary equipment.
- Implement the tech transfer strategy your product requires.
- Train your staff, from technical profiles to commercial teams.
- Design the preclinical and clinical strategy your product needs.
- Develop the regulatory strategy for your product (IVDR, MDR, PIF, CTD…).
- Design the market access strategy for your product.
- Conduct specific biotech supplier audits.
Medical Devices (MDR and IVDR)
- Obtaining import/export licenses for medical devices.
- Preparing risk management reports and product risk management plans: ISO 14971.
- Designing, developing, and implementing the IVDR performance evaluation plan.
- Support in the validation of medical software: EN82304 and EN62340.
- Regulatory classification of products: MDR, IVDR.
- Designing preclinical experimental plans for medical devices: IVDR and MDR.
- Project management/coordinating.
- Designing, developing, implementing, and maintaining quality assurance systems: ISO 13485 and ISO 15189.
- Conducting national and international audits. Internal, external, and supplier audits.
- Managing the software design and validation plan for medical devices.
- Managing and preparing the prior operation license with AEMPS (Spanish Agency for Medicines and Health Products).
- Modifying/renewing the operation license with AEMPS (Spanish Agency for Medicines and Health Products).
- Preparing and conducting the Quality Management System review by management.
- Supporting during the Notified Body audit.
We help you
Foundations, Hospitals, and Research Centers
- Design facilities and quality plans that best suit your product.
- Evaluate your preclinical and clinical trials based on the applicable regulations.
- Design and develop the regulatory strategy your product needs.
- Train your scientific personnel in pharmaceutical regulations (GxP training).
- Validate your analytical methods and support you in process validations and qualification of equipment and facilities.
Cosmetic Manufacturers
- Facility and quality system audits.
- Design, development, implementation, and maintenance of quality assurance systems: ISO 22716.
- Conducting national and international audits. Internal, external, and supplier audits.
- Request for cosmetic product certificate.
- Responsible declaration for manufacturing and/or importing cosmetic products.
- Preparation of information dossiers and notifications.
- Preparation of the safety report.
- Notification to the European portal.
Nutraceuticals
- Dietary Supplements
- Registration of the responsible company in the RGSEAA register
- Communications for the first product placed on the market
- Modifications and cessation of activity
- Registration of new foods
- Preparación de expedientes regulatorios para HEALTH CLAIMS, NOVEL FOOD Y AUMES.
Other sectors
Investors and Investment Funds
Universities and Training Schools
Monday - Friday: 9:00 - 19:00 h.
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