Regulatory Affairs and Quality Systems Consultants to the Pharmaceutical, Biopharmaceutical and Medical Device Industry

DBT provides an array of services ranging from governmental affairs, product approvals, quality systems development and specialized training with services directed at the pharmaceutical, biopharmaceutical, medical device and in vitro and molecular diagnostic manufacturers.

DBT excels in helping companies develop quality and regulatory strategies resulting from:

  • prospective assessment of the quality system
  • corrective and regulatory actions
  • due-diligence
  • risk Assessment and management

DBT specializes in the scientific and technical aspects of quality systems and regulatory affairs including DIOPQ’s, process validation strategies, analytical methods characterization and validation, validation for compendial and non-compendial assay systems, and process control systems.

Please contact us - we welcome the opportunity of discussing your requirements in confidence.

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