At TECNALIA, as a CDMO (Contract Development and Manufacturing Organisation), we offer a wide spectrum of services for third parties, such as: formulation and analytical development, scaling and manufacture of pilot batches, quality control and batch release, stability studies, pharmacogenetics, clinical trials from phase I to IV and manufacturing for third parties.
We provide pharmaceutical development projects with more than 3,000 m2 of state-of-the-art laboratories focusing on the following services:
- Galenic and analytical development.
- Scaling and manufacture of pilot batches.
- Quality control and registration batches.
- Stability studies.
- Bioequivalence and clinical trials.
- Pharmaceutical third-party manufacturing.
We provide rapid, flexible and customised solutions:
Through our integrated management of pharmaceutical development projects, we support pharmaceutical companies in their compliance of market time limits in all stages, from research to the clinical stage. To do so:
- We support our customers to move rapidly through the development value chain.
- We screen and develop complex formulations until their manufacture.
- We accelerate the development and extension of processes in compliance with GMPs.
- We manage and carry out clinical trials.
- We guarantee regulatory compliance; possibility of regular meetings between technical teams for proper project monitoring.
- Easier monitoring of the programme.
- Use of our technicians’ knowledge in regulatory requirements.
- Rapid solution of technical problems.
- Lower auditing costs.
- Pharmaceutical laboratories.
Certificates and Recognition
The Pharmaceutical Development Control Laboratory is certified by the Spanish Agency for Medicines and Healthcare Products (AEMPS) in Good Manufacturing Practice (GMP) guidelines: Physical and chemical quality control medicines for human use and medicines under research.
The manufacturing plant is certified by the Spanish Agency for Medicines and Healthcare Products (AEMPS) in Good Manufacturing Practice (GMP) guidelines: Manufacture and import of pharmaceuticals for non-sterile human use, including psychotropic and narcotic substances / Manufacture and import of non-sterile investigational medicinal products.
The drug manufacturing plant has been granted the ISO 13485 certification for quality management for the medical devices industry.