Company

Gradocell was born with the intention to support biotech companies, healthcare providers and research organizations with their development and manufacturing projects in the field of Advanced and Innovative Therapies for human or veterinary use. To this end the company provides:

  • Quality and technical advice
  • Training
  • Technology transfer management
  • Quality Audits
  • Preparation of documentation
  • Management of the processes associated with regulatory authorizations.

Our team consists of highly qualified professionals that pioneered the development of some of the earliest projects in the Advanced Therapies field in Europe. Since then, our team has gained a wealth of experience in the implementation of manufacturing regulations, the management of clinical trial applications and obtaining market and hospital use authorizations for several cell, gene and tissue engineering products.

After more than ten years in the field we are experts in designing and implementing the full range of processes that encompass manufacturing, control, validation, documentation and regulatory affairs. Our team comes from some of the pioneering European companies that started applying industrial quality to the manufacture of Advanced Therapies and Innovative Medicines leading to their use in the first clinical trials in Spain.

At Gradocell we collaborate with companies as well as public and private research and healthcare organisations to ensure their compliance with the quality standards required by current regulations.

In addition we work alongside leading engineering companies to design and set up the required manufacturing facilities.

Our goal is to become the reference advanced therapy consulting company in Spain and the preferred partner of companies and research laboratories developing novel advanced therapy and innovative medicine projects.

Due to our specialisation, we are uniquely positioned to offer a unique service in this sector.

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