HELP WITH SURFING:





PAGE MAIN CONTENTS

Tecnalia. Inspiring Business

Tecnalia. Inspiring Business

Pharmaceutical Development Laboratory

TECNALIA has the experience and necessary infrastructure to carry out the development of the formulation of a wide range of products.

With over 15 years of experience, the work philosophy of the Pharmaceutical Development Laboratory is based on concern and awareness of R&D problems in the pharmaceutical sector in accordance with our clients' needs.  We have a young yet qualified team to face any innovative challenge that may arise in the pharmaceutical field and respond with timely solutions; as well as high performance equipment and a strict quality system.

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.) and Semi-solids (gels, creams, ointments, etc.).

 

Pharma Development Tecnalia

boton-serviciostecnologicos-en

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.

ANALYTICAL DEVELOPMENT

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

STABILITY STUDIES

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

EQUIPMENT

  • Electronic scales.
  • Differential Scanning Calorimetry (DSC).
  • Volumenmeter.
  • V Mixer.
  • Eccentric press machine and rotary press machine.
  • Automatic encapsulating.
  • Fluid bed.
  • Paila coating.
  • Rotolab.
  • Lyophilizer.
  • Spray-Dryer.
  • Blistering machine.
  • Extruder-spheroniser.
  • Oven muffle.
  • Climatic chambers.
  • Chromatographs for UHPLC, HPLC (UV / VIS and fluorescence) and for HPLC -MS.
  • Dissolution tester and fraction collector.
  • Spectrophotometers.
  • Durometers.
  • Friability tester.
  • Solid forms disintegration tester.
  • Electronic Moisture Analyzer.
  • Rheometer.
  • Viscometer.
  • Laser Diffraction Particle size Analyser and coulter.
  • Karl-Fischer.

 ACREDITATIONS AND RECOGNITIONS

  • ISO 9001
  • Good Manufacturing Practices (GMP) - Pharmaceutical development and manufacturing.
  • Good Laboratory Practices (GLP) - Pharmaceutical development.
  • Spanish Medicines Agency (AEMPS) inspection with positive result - Clinical trials and Bioanalysis.
  • We work under Good Clinical Practices (GCP) - Clinical Trials Unit.

Access to our Acreditations and Recognitions

LINES OF INNOVATION / AREAS:

  • New pharmaceutical release forms.
  • Reformulation of active ingredients.
  • "Reprofiling" of brand drugs.
  • Clinical trials of inhaled medications.
  • Development and clinical validation of food supplements.
  • Monitoring of allergenic extracts.
  • Diagnostic, prognosis and response to drug tests.
  • Companion Diagnostics.
Pharmaceutical Development Laboratory

Contact

Goyo Ortiz de Urbina

M. +34 649 865 410

Related Laboratories


WEB HEADER

Tecnalia - Inspiring Business

SEARCH ENGINE



PAGE FOOTER

© 2019 Tecnalia. All rights reserved.

Parque Científico y Tecnológico de Bizkaia. Astondo Bidea, Edificio 700. E-48160 Derio. Bizkaia (Spain). Tel.: 902.760.000 - International Calls: (+34) 946.430.850


HELP WITH SURFING: