Our Services
REGULATORY
Comprehensive regulatory support for innovative products: Biological medicines, advanced therapies, small molecules, medical devices (MDR and IVDR), cosmetics, and dietary supplements.
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Medicines for Human and/or Veterinary Use
Discover everything we can do at Konexio Biotech for your business related to human and/or veterinary medicines.
- Regulatory support and development of the strategy to follow (ROADMAPS)
- Review of the integrity and accuracy of regulatory documents
- Preparation and submission of regulatory dossiers to regulatory authorities
- Conducting regulatory audits on registration dossiers
Medicines
- Strategy to follow for obtaining approval faster (roadmaps), supervision (dossier audits), and project management
- Scientific consultations with regulatory agencies
- Review, evaluation, and development of all modules:
Module 1: ERA, PV System, RMP, Packaging Materials, and Readability Testing
Module 2: Experienced personnel with academic and professional training (MD, PhD)
Module 3: Quality
Module 4: Non-clinical
Module 5: Clinical
Medical Devices
- Generation of risk management plans for products
- Obtaining manufacturing, importation, sterilization, or grouping licenses
- Qualification and regulatory classification of medical devices
- Preparation of technical dossiers for MDR and IVDR products
- Coordination of “In House” manufacturing products
- Coordination with Notified Bodies
- Obtaining CE marking
Cosmetics
- Request for Cosmetic Product Certificate
- Declaration of responsibility for manufacturing and/or importing cosmetic products
- Preparation of information dossier and notification
- Preparation of safety report
- Notification to the European portal
Nutraceuticals
- Food supplements
- Registration of the responsible company in the RGSEAA (General Registry of Food Supplements)
- Communications for the first product placed on the market
- Modifications and cessation of activity
- Registration of novel foods
Our Work Process
Discover the work process we follow at Konexio Biotech to shape your project in a comprehensive way.
Step-01
Initial Regulatory Analysis
We assess the applicable regulatory framework for the product, including the target region and the necessary classifications for compliance.
Step-02
Development of Regulatory Strategy
We design a clear and customized roadmap to meet the requirements of the competent authorities, optimizing time and resources.
Step-03
Preparation of Dossiers
We prepare technical and regulatory files, including modules on quality, safety, and efficacy, ready for submission to regulatory authorities.
Step-04
Management of Regulatory Interactions
We act as intermediaries with agencies like EMA or FDA, managing inquiries, clarification requests, and file updates.
Step-05
Post-Approval Support
We monitor and manage regulatory changes, license renewals, and necessary updates to maintain compliance after product approval.
Want to learn more about Regulatory Affairs?
We offer device classification, preparation of technical files, audit readiness, and support in obtaining the CE mark and other global approvals.
We act as a direct liaison with agencies such as the FDA, EMA, and local authorities, facilitating meetings, scientific consultations, and regulatory submissions.
We assist in the preparation and submission of Investigational New Drug (IND) applications and Clinical Trial Applications (CTA), ensuring compliance with the specific requirements of each region.
Yes, we have experience in regulatory registrations across the Americas, LATAM, Europe, Asia, and other emerging markets.
We monitor regulatory changes and help maintain compliance through timely updates to regulatory files and product documentation.
Yes, we ensure that labeling materials comply with national and international regulations and are clear for both patients and healthcare professionals.
We have worked with CAR-T, gene therapies, and orphan drugs, providing regulatory strategies tailored to these innovative technologies.
We evaluate the specific requirements for combination products and develop regulatory strategies that cover both the pharmaceutical component and the device.
Yes, we conduct internal and supplier audits to identify areas for improvement and ensure compliance with regulatory standards.
Yes, we prepare companies for inspections and assist them during and after the process to address any findings.
Monday - Friday: 9:00 - 19:00 h.
