Our Services
REGULATORY PRECLINICAL
Regulatory preclinical services: Gap analysis studies. Preparation of regulatory preclinical plans.
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Human and/or Veterinary Medicines
Discover everything we can do for your business in everything related to human and/or veterinary medicines.
- Conducting regulatory audits of non-clinical data: Biologics, Advanced Therapies, Small Molecules...
- Creation of regulatory roadmaps.
- Design of preclinical experimental plans for drugs: Advanced Therapies and biologics.
- Conducting scientific advisory consultations with regulatory agencies: EMA, FDA, ENVISA, AEMPS (Spanish Agency for Medicines and Health Products)...
- Sourcing non-clinical suppliers.
- Conducting GLP audits of suppliers.
- Biostatistical analysis of results.
- Project management/coordinating.
Medical Devices (MDR and IVDR)
Discover everything we can do for your business in everything related to Medical Devices (MDR and IVDR).
- Risk management report and product plan: ISO 14971
- Risk management and process report: ISO 31000
- Design, development, and implementation of the IVDR performance evaluation plan.
- Support in medical software validation: EN82304 and EN62340
- Regulatory classification of products.
- Design of preclinical experimental plans for medical devices: IVDR and MDR
- Project management/coordinating.
Our Work Process
Discover the process we follow at Konexio Biotech to shape your project in a comprehensive way.
Step-01
Regulatory Classification
We classify your product within the lowest regulatory framework.
Step-02
Creation of a Regulatory Roadmap
We generate a personalized technical and financial roadmap and seek out your best suppliers.
Step-03
Design and Execution of the Non-Clinical Package
We audit and design your personalized regulatory preclinical plan for your product.
Step-04
Preparation of Scientific Advice with the Regulatory Authority
Always in close collaboration with the regulatory body.
Want to Discover More About Regulatory Preclinical?
Regulatory preclinical, or non-clinical, refers to the phase of product development before it is tested on humans. It applies to medications, medical devices, cosmetics, and nutraceuticals.
Yes. During the development of regulatory preclinical plans, we evaluate and audit all experiments conducted on a product, both in-person and remotely.
Yes. Prior to executing preclinical tests (such as toxicology studies, biocompatibility testing, etc.), we conduct GLP audits for laboratories both nationally and internationally.
Yes. Once the regulatory preclinical plan is designed, we prepare the regulated procedure for scientific advice with both the EMA and FDA. We assist you in preparing the documentation, submitting it, and following up on any deficiencies or comments from the regulatory body.
Yes. We can even assemble it from scratch, including the M2 summary section.
No. Our preclinical plans are tailored to each product type. We work with both biotechnological products and Advanced Therapies, as well as synthetic chemistry products. Wherever there's an innovative product, we're there!
Yes, for both MDR and IVDR.
You can reach us through our contact email.
Monday - Friday: 9:00 - 19:00 h.
