Quality Assurance
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.
- Internal audits
- 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.)
Technical legal advice
We advise from the scientific and/or operating techniques, methods or necessary resources point of view, to develop or validate the most suitable technical solution:
- Development and/or evaluation of analytical methods
- Elaboration and execution of protocols and programs of stability
- Advice on ISO 17025.
- Evaluation and advice on analytical methods transfer
- Optimization of quality control resources
- Drafting of Technical/Quality Systems Documentation (Site Master File, Protocols, SOP´s)
Regulatory Affairs
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
Engineering
We advise on the design, qualification and validation of systems.
- Advice on the design of new facilities in the pharmaceutical and cosmetic industry
- Validation of Microsoft Excel books
- Review of protocols and Validation/Qualification reports at the DQ, IQ, OQ, PQ level, as well as the development of URS (User Requirements Specification)
- Validations of computer systems