GMP, GCP,GLP and GDP Consultancy
We help you to gain the strategic perspective to help you fulfill your regulatory needs and we´ll be at your side in the event of an inspection or audit.
We help organisations to implement a quality system which is based on a broad strategic vision to fulfill GxP regulatory needs in each of your activities in order to eliminate risks, optimize resources and be prepared for inspections or audits, be they by clients and/or regulatory entities.
From our global fulfillment approach for an organisation down to the solution of incidents detected by either a regulatory agency, an internal audit or even your own client, with this wide-range of possibilities available to us we are able to formulate an offer to cover your real needs.
Development of policies and a methodology for the integration of QbD into your organisation:
The need to have available qualified equipment and installations as an element to demonstrate that a suitable manufacturing process is inherent to every process of regulatory fulfillment in the manufacture of API, final pharmaceutical forms and bio-technology.
The growing need for regulatory fulfillment now extends to the distribution of medicines.
The total management of the daily needs identified in the area of R&D, and mainly in clinical/biomedical research, requires qualified specialists and with demonstrated level of experience in this sector.
(Spanish Biomedical Research Law 14/2007) and clinical research (ICH E6 R1 y R2, GCP)