We evaluate, design and/or optimize quality systems:
External audits to suppliers of raw materials, packaging material, analytical services laboratories and manufacturers of finished products. Follow-up and tracking the adequacy and effectiveness of the necessary corrective/preventive actions and measures to correct the detected deviations.
Evaluation and advice prior to GMP, GDP and Good Practices in the Cosmetic Industry compliance inspections
Design and development of the pillars of a Quality System and the documentary system derived from it
Consultancy on Systems and monitoring of CAPA, change controls, OOS and risk analysis
Elaboration and/or appraisal of the annual product review, PQR (Product Quality Review)
Drawing up of Quality System Documents (protocols, quality manual, qualification/calibration plans and programs, etc.)
Regulatory advice throughout the entire life cycle of the drug, both in medicines for human use (innovative, generic and biosimilar, OTC and line extensions), as well as for veterinary drugs or medical devices.
Advice and development of ASMFs (DMFs), documentation for CEPs request to EDQM and IMPDs
Standardization, presentation strategy, documentary advice and elaboration of variations (IA, IB and II)
Right First Time Oriented Activities: Pre-evaluation of dossiers and corrective advice on potential deficiencies found as activity prior to the application for the marketing authorization and/or presentation of variations to the Regulatory Agencies
Preparation of expert reports (QOS)
Regulatory Due Diligence/Regulatory Audit of products and complete portfolios in buying/selling actions among companies
Strategy and development of Test Legibility of Prospects and Bridging Reports
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