Gxp Support

GxP support provides services in clinical research and pharmaceutical industry on high level of quality. In the field of Clinical Research our company provides our clients with administrative support, coordination and project management of clinical trials, remote monitoring of clinical trials, eTMF maintenance, quality review of eTMF, GAP assessment, review of SOPs and advice on improvement, preparation for inspection and audits, conducting GCP audits: eTMF audit, vendor audit, investigational site audit, process audit. In these areas we can provide highly qualified and experienced colleagues for contract positions as the need arises. In the pharmaceutical industry we provide support to our clients in the field of quality assurance. Our colleagues have decades of experience in the field of quality assurance. We carry out the review and maintenance of QMS systems, supplier qualification and audits. We undertake the preparation for official inspections and audits, review of Batch records, preparation of CoAs and management of CMO partners. Carrying out GMP audits in the following areas : API manufacturing, finished product manufacturing, packaging (primary, secondary), warehousing, logistics, QC laboratories, contract manufacturers and contract laboratories.