Telstar reinforces its pharmaceutical consulting area

Having completed the acquisition process of dTC Development Team Consulting, Telstar strengthens its ability to develop quality systems in GXP environments

The group has reinforced its pharmaceutical consulting area by adding a new line of consulting and deployment services for QbD (quality by design) systems.

The company has also enhanced its consulting and deployment service for R&D and pharmacovigilance quality systems.

Telstar consolidates its standing as the only company capable of offering a global and comprehensive pharmaceutical consulting service.

Telstar has reinforced its pharmaceutical consulting area by driving two new business lines that will offer consulting services for quality systems in GXP environments. Specifically, Telstar has incorporated a new Quality by Design (QbD) deployment service, and has expanded its R&D quality systems service for the preclinical (GLP) and clinical (GCP) phases in the development of active ingredients and drugs, as well as for pharmacovigilance in the marketing phase.

The expansion of Telstar’s consulting services portfolio took place on February 1, 2013, when the Catalonian company acquired dTC Development Team Consulting’s business. dTC Development Team Consulting, which has been in business since 2000, is highly specialized in executing projects that deal with GXP regulatory compliance and with the improvement of manufacturing processes based on Quality by Design concepts. With the integration of dTC’s know-how into its business, Telstar now stands strengthened as the only Spanish company capable of offering a global pharmaceutical consulting service that encompasses the entire drug life cycle.

Quality by Design in product development, manufacturing and marketing of drugs and API’s is a win-win strategy oriented toward achieving robust and efficient processes, which leads to a quality assurance for the product with costs optimization. Efficiency in manufacturing processes reduces inspection efforts and product related non-quality costs. It is a highly competitive methodology when compared with the traditional quality assurance system based primarily on final inspection and control, which is clearly less efficient.

The regulatory framework to work in QbD is firmly established, and the latest GMP updates require adapting quality systems to the new, risk management-based models, and adapting production systems to permit continuous process monitoring and verification. In fact, and as of January 2013, the US FDA requires the use of QbD methodology for the drug marketing authorization process of generic products.

The integration of this specialized service enables Telstar to position itself as a leading provider of GLP services for nonclinical development, GCP services for clinical development, QbD services for process development and redesign, PAT/NIR services for process monitoring and control and GMP services for GMP production and operational excellence.

The full range of Telstar’s consultation services has now been consummated by the incorporation of these two business lines, with services related to Regulatory Affairs and Compliance in the life sciences sector.

Telstar develops global engineering, construction, equipment and services solutions for the life sciences market (pharmaceutical and biotechnology industry, hospitals, laboratories and research centers). It both designs and manufactures integrated process equipment, and also designs and builds turnkey pharmaceutical and biotechnology facilities and plants by coordinating and executing all project phases: engineering, consulting, construction, critical systems installation, equipment design and manufacture, professional staff training, validation, quality assurance, and start-up. Telstar operates in more than 100 countries and has production plants, technological excellence, engineering and consulting centers, and sales offices throughout the world. Headquartered in Terrassa (Barcelona), Telstar has a professional team of 900 people. Telstar’s Consulting Unit features centers in Spain, Brazil, Argentina, Portugal, Italy, China and India, with a specialized professional staff of 100 people.
For more information:
TELSTAR
Phone: +34 93 736 16 00
Website: www.telstar.eu
E-mail: marketing@telstar.eu