Companies

NATIONAL
INTERNATIONAL

National Companies

VIRALGEN VECTOR CORE

  • Technical and regulatory advice for the construction and validation of a facility for the manufacturing of AAV viral vectors therapy.
  • Specialized training in GMP for Advanced Therapy Medicinal Products (ATMPs).
  • GMP audit for the manufacturing of AAV viral vectors therapy.
  • Preparation of CMC for the presentation of the application for an IND for a gene therapy medicine.

SYNGOI

  • Advising and collaboration with Engineering in the design of a new manufacturing facility in Derio, Vizcaya.
  • Initial Scientific Advice for the new facilities for the Inspection and Control Department of AEMPS.

TYRIS

  • Technical advice for the classification of a Gene Therapy Medicine at EMA (European Medical Agency).

CLINICA DKF

  • Advising on the Development of Strategies and the use of Advanced Therapy Medicinal Products (ATMPs) for Regenerative Medicine.

IMERETI

  • Specialized training in the Development of Advanced Therapy Medicinal Products (ATMPs).

MR2LAB (XCELL Medical Solutions)

  • Scientific advice on AEMPS for the classification, design and development of a Cell Therapy product.
  • Advising on the Development and Marketing of Advanced Therapy.

HISTOCELL

  • Technical advice on the adaptation and expansion of facilities with classified areas.
  • GMP audit of the facilities/Cell Therapy Medicine manufacturing.

PRAXIS BIOPHARMACEUTICALS

  • GMP audits for the manufacturing of Cell Therapy medicines.
  • Feasibility plan for the manufacturing of Gene Therapy medicines.
  • Support in the preparation of specifications and validation of suppliers.

EQUICORD

  • Implementation of GMP regulations for Cell Therapy for veterinary use.
  • GMP certificate issued by AEMPS.
  • Technology transfer to a third-party manufacturer (CMO). Technical and regulatory advice for the development of an Advanced Therapy Medicinal Product (ATMP) for veterinary use. Creation of internal documentation in compliance with GMP regulations.

VIVEBIOTECH

  • Implementation of GMP regulations for the manufacturing of viral vectors for use in Advanced Therapy Medicinal Products (ATMPs).
  • GMP certificate issued by AEMPS.
  • Technology transfer and Technical and Regulatory Advice for the development of a Gene Therapy medicine.

TIGENIX, SAU

  • Regulatory and Quality support.
  • Management of the Company’s corporate Quality System.
  • GMP audits for the manufacturing of Cell Therapy medicines.

CORETHERAPIX, SLU

  • Management and Maintenance of the Quality System. Support in logistics and medication management in the CAREMI Clinical Trial.
  • Management and technical advice for the Technology Transfer of the manufacturing process of cardiac stem cells to a CMO.
  • Training in Quality issues.

GENETRIX /SILO

  • Regulatory advice, project evaluation and technology transfer of Advanced Therapies and Innovative Products.

SPHERUM BIOMED, SL

  • Technical and documentary advice for the development of a viral vector manufacturing platform.

BIODAN

  • Regulatory advice for the development of Tissue Engineering Medicines.

CITOSPIN

  • Project to scale up the manufacturing process of a cell therapy medicine for allogeneic use. 
  • Regulatory advice: scientific advice on AEMPS.

CLINICA DIAGONAL

  • Preparation and presentation of the CTD for the authorization of use of an advanced therapy medicinal product (ATMP) of non-industrial manufacturing.
  • Regulatory advice: scientific advice on AEMPS.

CLINICA CEMTRO

  • Technical and regulatory advice for the scaling of the manufacturing of allogeneic chondrocytes.
  • Scientific advice on AEMPS.

TECBIOCEL

  • Scientific advice on AEMPS for the development of pre-clinical ATMP for COVID-19.
  • Scientific advice on AEMPS for the design and development of a Cell Therapy Medicine.
  • Authorization and GMP certificate issued by AEMPS.

CLÍNICA DERMATOLÓGICA ERCILLA, SLU

  • Technical and regulatory advice for the development of an alopecia treatment using stem cells and growth factors.

PROPOSIT SL

  • Collaboration project for the technology transfer and marketing of a method for obtaining PRP.
  • Audit in compliance with the Regulations of Use of Platelet Rich Plasma. 

REGENIA, SL

  • Technical and documentary advice for the certification of a pharmaceutical laboratory for the manufacturing of growth factors derived from platelet-rich blood plasma.

BIOHOPE

  • Design of Quality System for R&D activities.

BIC GUIPUZKOA

  • Preparation and review of documentation related to biosafety and work standards in the facilities of the bio-incubator of companies.

CELLUS BIOMEDICA

  • Strategic advice for the Cellus project in Spain: planning and Project Evaluation.

POLIMERBIO

  • Business plan for a medical polymers manufacturing company.

ALGENEX

  • GMP Diagnosis Audit for the manufacturing of an insect-based biotech product.
  • Technical advice on the facility design for the production of an insect-based biotech product.

MIKROBIOMIK

  • Scientific advice on AEMPS for the development of a gut microbiota product.

QUATRE S.L.

  • GMP and technical training. Advising on the implementation of the GMP Quality System.

International Companies

SEVIBE

Poland—

  • GMP audit of facilities/manufacturing in the Polish Stem Cell Bank.

BEBEVIDA

Portugal—

  • GMP audit of the facilities of the Cord Blood Bank (Oporto).

STEMMATTERS

Portugal—

  • GLP audit of the pre-clinical CRO responsible for non-clinical safety studies. 

CELLS FOR CELLS

Chile—

  • Specialized training in the Development of Advanced Therapy Medicinal Products (ATMPs).

LABORATORIOS LEGRAND

Bogotá, Colombia—

  • Audit of facilities, processes and Quality Management System (QMS) of the Keraderm Laboratory in Bogota.

IPS – UNIVERSIDAD DE ANTIOQUIA

Medellin, Colombia—

  • Audit of facilities, processes and Quality Management System (QMS) of the Cell Therapy Laboratory and Biobank of IPS-Universidad Antioquia.

CELLAB

Andorra—

  • Technical advice on the adaptation and expansion of facilities with classified areas. Feasibility study.
  • Implementation of GMP regulations for the manufacturing of ATMP. Strategy consulting for the development and marketing of medicines.

VISCOFAN NATURIN, GmbH

Germany —

  • Preparation of an IMPD for a clinical trial.
  • Technical and regulatory advice for the development and marketing of a Cell Therapy Medicine. Technology Transfer to a third-party manufacturer (CMO).

MEDXCELL

Switzerland—

  • Scientific advice on the Swiss Medicine Agency, Swissmedic: advice on the design of the clinical trial, and pre-clinical and clinical studies.
  • Evaluation, selection and validation of a CDMO for the manufacturing of a Cell Therapy Medicine based on mesenchymal cells.

CELLUS BIOMEDICA

Chile—

  • Strategic advice for the Cellus project in Spain: planning and project evaluation.

Hospitals

Public and private hospitals

See hospital portfolio

Foundations and official institutions

See foundation portfolio

Teaching

Master´s, postgraduate courses and seminars.

See teaching portfolio

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