Tecnalia Research & Innovation

About Tecnalia Research & Innovation

TECNALIA Pharma Labs is a full-service Contract Development, Manufacturing Organization (CDMO) that provides high quality services under a strong quality system, with over two decades serving the pharmaceutical industry. We provide comprehensive services across the entire value chain (human medicines, medical devices, food supplements, cosmetics & veterinary medicines). • Pharmaceutical development: Galenic & Analytical Development, Stability Studies • Manufacturing: Contract Manufacturing of Industrial Batches for third parties • Pharmacogenetics. TECNALIA also offers development and efficacy assessment of Pharmaceutical OTC products against blood-sucking arthropods. 

Certifications
Categories
  • ES
  • 2016
    On CPhI since
  • 3
    Certificates
Contract Service
Contact info

Products from Tecnalia Research & Innovation

  • GALENIC DEVELOPMENT

    Product GALENIC DEVELOPMENT

    TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract Manufacturing

    GALENIC DEVELOPMENT
    • Preformulation studies.
    • Design and galenic development of innovative, generic and advertising (OTC) medicines.
    • Design and galenic development of new dosage forms.
    • Compatibility studies of active ingredients and excipients.
    • Design of manufacturing processes.
    • Transfer of manufacturing technology and "in situ" support.
    • Reporting Expert.
    • Patents study

    TECNALIA´s Pharmaceutical Development Laboratory is accredited by the Spanish Medicines Agency (AEMPS) in Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

    We offer solutions in several dosage forms formulation:
    Solids (tablets, capsules, sachets, etc.)
    Liquids (suspensions, solutions, syrups, etc.).
    Semi-solids (gels, creams, ointments, etc.).



  • ANALYTICAL DEVELOPMENT

    Product ANALYTICAL DEVELOPMENT

    TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract

    Manufacturing
    ANALYTICAL DEVELOPMENT

    • Monitoring of the first industrial manufacturing batches.
    • Characterization of raw materials according to Pharmacopoeia.
    • Development and validation of analytical techniques.
    • Quantification of active ingredients, impurities and degradation products in raw materials and medicines.
    • Transfer of analytical techniques.
    • In vitro dissolution profiles.

    TECNALIA´s Pharmaceutical Development Laboratory is accredited by the Spanish Medicines Agency (AEMPS) in Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

    We offer solutions in several dosage forms formulation:
    Solids (tablets, capsules, sachets, etc.)
    Liquids (suspensions, solutions, syrups, etc.).
    Semi-solids (gels, creams, ointments, etc.).
  • STABILITY STUDIES

    Product STABILITY STUDIES

    TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract Manufacturing
    We offer Stability Studies in short and long term,
    according to ICH standards.

    • Batchs of Registration.
    • Industrial batches of finished product (Release, changes, etc.).
    • Ongoing.
    • Bulk product.
    • External management of stabilities.
  • MANUFACTURING OF BATCHES FOR CLINICAL TRIALS

    Product MANUFACTURING OF BATCHES FOR CLINICAL TRIALS

    TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract

    Manufacturing
    Manufacturing of Batches for Clinical Trials /

    • Importation of active substances and medicines.
    • Manufacturing of placebos, medicines, food supplements.
    • Design of blinding strategy.
    • Labelling for primary and secondary packaging.
    • Storage Good Manufaturing Practices (GMP) conditions.
    • Shipping management to the different centers.
    • Return, reconciliation and destruction of drugs.

    TECNALIA has a unique facility (Pilot Plant / Pharmaceutical Laboratory) to provide ample opportunities for scaling and manufacturing of medicines, medical devices, cosmetics and food suplements, always in the most stricter compliance of GMP certification.
  • PILOT BATCHES AND REGISTRATION BATCHES CONTRACT MANUFACTURING

    Product PILOT BATCHES AND REGISTRATION BATCHES CONTRACT MANUFACTURING

    TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract ManufacturingPilot

    Batches and Registration Batches /

    • Manufacture in compliance with the principles and guidelines of GMP for medicinal products.
    • Transfer of analytical techniques.

    TECNALIA has a unique facility (Pilot Plant / Pharmaceutical Laboratory) to provide ample opportunities for scaling and manufacturing of medicines, medical devices, cosmetics and food suplements, always in the most stricter compliance of GMP certification.
  • COMPANION DIAGNOSTICS -Pharmacogenetics

    Product COMPANION DIAGNOSTICS -Pharmacogenetics

    TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract Manufacturing.

    The activities of TECNALIA´s Genetic and Molecular Biology Grop on the Biomedical sector aim to bring P4 Medicine (Predictive, Preventive, Personalized and Participatory) to patients and professionals.
    In this regard, the Genetics and Molecular Biology Laboratory devotes a significant portion of its resources to develop assays and in vitro tests for disease diagnosis, prognosis and prediction of drug response (Companion Diagnostics).

    Personalized /
    • Proper treatment at the right dose.
    • To the right patient / disease.
    • At the right time.
    • For the right outcome.

    Predictive /
    • Prediction of response to therapy.
    • Efficiency vs toxicity.

    Preventive /

    Evaluate risk and predisposition to
    certain diseases.
    It allows the adoption of preventive measures to delay, or even eliminate, the occurrence of the disease or early diagnosis.

    Participatory /
    To involve the patient in the management of his/her disease: treatment options, prevention strategies, monitoring of the disease and risks.
  • GENETIC DIAGNOSIS - Pharmacogenetics

    Product GENETIC DIAGNOSIS - Pharmacogenetics

    TECNALIA, experts in Pharmaceutical Development, Scale-up & Pilot Batches Manufacturing, Clinical Trials and Contract Manufacturing

    TECNALIA´s Genetic and Molecular Biology  Lab develops a strong activity in the field of Genetic Diagnosis, focused on three main areas:
    • Diagnosis of hereditary syndromes (tumoral and non-tumoral).
    • Diagnosis of neoplastic diseases.
    • 3Preimplantation genetic diagnosis.
    TECNALIA´s Genetic and Molecular Biology is EMQN certified for Heredetary Breas Cancer and Lynch Syndrome genetic t

    Equipment /
    Laboratory (220 m2) consists of three
    different areas, two of which are intended
    to the preparation and handling of
    samples and are equipped with systems
    to control air temperature, humidity and
    pressure.
    Among the main equipment includes:
    • Next Generation Sequencing.
    • Microarray Scanner.
    • 3130xl Genetic Analyzer.
    • Real Time PCR.
    • Flow cytometer.
    • Image analysis system.
    • Microplate reader.
    • Thermalcyclers.
  • DEVELOPMENT AND EFFICACY EVALUATION OF PHARMACEUTICAL OTC PRODUCTS AGAINST BLOOD-SUCKING ARTHROPODS

    Product DEVELOPMENT AND EFFICACY EVALUATION OF PHARMACEUTICAL OTC PRODUCTS AGAINST BLOOD-SUCKING ARTHROPODS

    DEVELOPMENT AND EFFICACY EVALUATION OF PHARMACEUTICAL OTC PRODUCTS AGAINST BLOOD-SUCKING ARTHROPODS.TECNALIA offers standardized (WHO, EPA) and internal protocols regarding efficacy evaluation reports for product development and registration. Pediculicides against head lice crawling stages and eggs. Skin Repellents, Treated fabrics & Personal protection items against mosquitoes, ticks, bedbugs, sand flies and others. TECNALIA´s Urban Environmental Health Laboratory is the main Spanish Laboratory offering these services and working closely with the Spanish Medicines and Sanitary Products Agency (AEMPS). Among the services offered we can highlight: - Laboratory Studies - Taylor made” design and method validation - “Screening tests” for formulation selection - Advice on required test decision and regulatory consulting - Bibliographic reviews and patent studies

Tecnalia Research & Innovation Resources

  • Brochure TECNALIA Pharma Lab_services

    TECNALIA Pharma Lab_services: COMPREHENSIVE MANAGEMENT OF PHARMACEUTICAL DEVELOPMENT PROJECTS TECNALIA, Your best CDMO partner for drug developmentTECNALIA is a full-service Contract Development, Manufacturing Organization (CDMO) that provides high quality services under a strong quality system, with over two decades serving the Pharmaceutical industry. We provides a broad spectrum of pharmaceutical outsourcing services such as: formulation and analytical development, scale up & pilot batch manufacturing, quality control & batch reléase, stability studies, pharmacogenetics, phase I to IV clinical trials and contract manufacturing. TECNALIA also can develop and carry on efficacy testing of OTC products against blood-sucking arthropods (insect skin repellent and pediculicides).